Warning-Letter

Apotex - contamination www.apotexterror.homestead.com www.pharmaholocaust.com

I live like a walking death in twilight zone / some where in between death and a life being deprived of all Human Rights and Constitutional / Law

protection by habitual offenders. I was assessed by three (3) independent psychiatrists to eliminate offender's speculations about my insanity

prompting "delusions" etc. All psychiatrists stated clearly, that I am sane /I do NOT have/had any mental illness. No family history of any.

Apotex got second Warning Letter from FDA

Apotex Inc. 3/29/10

Department of Health and Human Services Public Health Service

Food and Drug Administration

Silver Spring MD 20993

Warning Letter

VIA FEDERAL EXPRESS MAIL

WL: 320 - 10 - 003

March 29, 2010

Mr. Jack M. Kay

President and COO

Apotex Inc.

150 Signet Drive

Toronto, Ontario, Canada M9L 1T9

Dear Mr. Kay:

During our July 27- August 14, 2009 inspection of your pharmaceutical

manufacturing facility, Apotex Inc. located at 150 Signet Drive, Toronto,

Ontario, Canada, investigators from the Food and Drug Administration (FDA)

identified significant violations of the Current Good Manufacturing Practice

(CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal

Regulations, Parts 210 and 211. These violations cause your drug products to

be adulterated within the meaning of section 501(a)(2)(B) of the Federal

Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that

the methods used in, or the facilities or controls used for, their

manufacture, processing, packing, or holding do not conform to, or are not

operated or administered in conformity with CGMP. In addition, our

inspection revealed that you failed to submit NDA Field Alert Reports (FARs)

to FDA as required by 21 C.F.R. § 314.81(b)(1) and section 505(k) of the Act

[21 U.S.C. § 355(k)].

The July - August 2009 inspection uncovered several violations that are

identical to those found during a December 10 - 19, 2008 inspection of your

Etobiocoke, Canada site that resulted in the issuance of a Warning Letter to

the Etobiocoke site in June 2009. These identical CGMP violations

demonstrated a lack of adequate process controls and raised serious

questions regarding your corporation's quality and production systems. This

prompted the FDA to place both sites under import alert on August 28, 2009,

whereby all finished drug products offered for entry into the United States

and manufactured at the Etobiocoke and Signet Drive, Ontario facilities are

detained without physical examination. Your firm has voluntarily recalled

approximately 659 batches of different products manufactured at this site,

and remains under Import Alert 66-40. However, this Warning Letter is being

issued because of serious and repeat violations from the 2008 and 2009

inspections and because your response, dated September 3, 2009, and

discussed below, is inadequate and lacks sufficient corrective actions.

Specific violations observed during the inspection include, but are not

limited, to the following:

CGMP VIOLATIONS

1. Your firm's quality control unit failed to follow the responsibilities

and procedures applicable to release of the drug product [21 C.F.R. §

211.22(d)].

For example, (b)(4), an Active Pharmaceutical Ingredient (API), batch

#HY2470, was found to be contaminated with (b)(4) materials. You rejected

part of this lot. However, you used a portion of this contaminated API to

manufacture Cetirizine HCl Film Coated Tablets, 10 mg batches #HY2910 and

#HY2912. These batches were released for distribution and shipped to the

United States.

Additionally, Metformin HCl (b)(4) batch #HT2731 was found contaminated with

(b)(4) particles identified as (b)(4) material, and charred material. This

batch was not rejected. Instead, it was used to manufacture Metformin HCL

(b)(4) tablets batch #HT2657, film coated into batch #HT2526, and packed

into finished drug product batch #HR7670. Batch #HR7670 was subsequently

released for distribution and shipped to the United States under batch

#JC2151 on March 4, 2009.

The inspection also documented your practice of repackaging and assigning

new batch numbers to products that failed the Acceptable Quality Level (AQL)

test. Your firm lacks a scientific rationale and documentation to support

this practice. For example, desiccant batch #HK8805 was used in

approximately 76 different products, 11 of which failed the AQL desiccant

leaking test. These 11 lots of contaminated Ranitidine Film Coated tablets

150 mg were initially rejected. However, 10 of these 11 lots were repackaged

into 500 count bottles using a new lot of desiccant, and assigned a new

batch number. These lots were then released for distribution without

assessing the potential impact the leaking desiccant could have on product

quality. You stated in your response that examination of retain samples for

the 11 lots did not confirm the presence of leaky desiccant. However, it is

possible that the absence of defective desiccant may be related to the

limited number of retain samples examined. In your response to this letter

please include a justification for the sample size and the corrective

actions you have implemented to prevent reoccurrence of these types of

events.

Your response reports that for the period of July 2007 to August 2009 your

firm had voluntary recalled all products associated with: a) deviation

reports, b) investigations of foreign components and material, and c)

products included in opened Field Alert Reports. This corresponds to the

immediate corrective action addressing this deficiency. However, your

response does not address other unacceptable practices such as returning

defective material back into inventory, or re-releasing failed material that

was inadequately reprocessed or retested without a scientifically sound

rationale and an assessment of potential impact to product quality.

Your corrective and preventive actions should include specific instructions

for reprocessing and conditions under which failed material can be

reprocessed and returned to inventory.

2. Your firm does not have adequate written procedures for production and

process controls designed to assure that the drug products you manufacture

have the identity, strength, quality, and purity they purport or are

represented to possess [21 C.F.R. § 211.100(a)].

For example, three initial process validation batches (#HP0793, #HP0706,

#HP0794) for Oxcarbazepine 300 mg tablets failed the dissolution test

specification (Q=NLT (b)(4)% at 30 minutes) and the batches failed to meet

the 30 minutes dissolution specification. Dissolution out of trend (OOT)

results were also obtained for Oxcarbazepine 150 mg and 600 mg tablets. The

same (b)(4) was used for the process validation of Oxcarbazepine 300 mg, 150

mg, and 600 mg tablets.

During your second attempt to perform the process validation, three batches

of Oxcarbazepine tablets 300 mg (lot #HT8606, #HT8607, and #HT8608) were

made from one (b)(4) that failed to meet the 30 minutes dissolution

specification. You released Oxcarbazepine 150 mg and 600 mg tablets that

were manufactured from the same (b)(4) that was used to manufacture the 300

mg strength. Your investigation Q-note 200071071 concluded that the

dissolution results were affected by the order in which the excipient

(b)(4), USP was added during the (b)(4) process. Appropriate process design

studies were not conducted to scientifically establish the correct order of

adding excipients, e.g., (b)(4), during the (b)(4) operation to ensure

proper dissolution of the drug product.

In addition, please explain your rationale for releasing different lots of

product (Oxcarbazepine 150 mg, 300 mg, and 600 mg) manufactured from the

same defective (b)(4).

3. Your firm fails to thoroughly investigate unexplained discrepancies or

the failure of a batch or any of its components to meet any of its

specifications, whether or not the batch has already been distributed [21

C.F.R. § 211.192].

For example, on March 31, 2008, during the preventive maintenance of the

(b)(4), yellow powder identified as residue of (b)(4) active materials and

several excipients were found behind the (b)(4) seals. Subsequently, on May

12, 2008, a yellow contaminant was found during the production of Ranitidine

HCL (b)(4) batch #HV9588 that led to the rejection of the batch. Your

investigations of these incidents are inadequate because the investigations

were not expanded to other lots manufactured in the same equipment prior to

March 31, 2008.

The inspection revealed several other examples of inadequate investigations

that did not extend to other batches of the same drug product, or other

products that may have been associated with the failure or discrepancy.

Specifically, investigation Q-note 200070632 involved the contamination of

Metformin HCl API batch #HP8402 with particles identified as (b)(4)

material, and charred material. You failed to assess all batches of finished

product manufactured with this contaminated API. Metformin HCl tablets batch

#HT2569, manufactured using the contaminated API, was released to the United

States without an evaluation into the potential impact to product quality.

Furthermore, your investigation (Q-note 200068475) into the appearance

failure of Lithium Carbonate 300 mg capsules (batch #HM6665) for missing

imprint on the capsules, did not include an evaluation of related batches

manufactured using the same batch of capsules lacking the imprint. In

addition, the remaining empty capsules in your inventory were not evaluated

for lack of imprint. Instead, they were used in the production of seven

other batches of Lithium Carbonate capsules and distributed to the United

States.

In addition, your product Metformin HCl (b)(4) lot #HL4695 was produced

using (b)(4), batch #HL8373. This batch of raw material was found to be

contaminated with charred (b)(4) and (b)(4).

It was used to produce 20 lots, including Metformin HCl 500 mg tablets and

Gemfibrozil 600 mg tablets that were released for distribution to the United

States. Your response lacks appropriate corrective actions to prevent the

use of contaminated raw materials in product manufacturing. We are concerned

with your organizational unit's lack of appropriate oversight in assuring

that procedures are followed during production and release, resulting in the

use of contaminated raw materials in the manufacturing process.

FDA's inspection of your Etobicoke, Ontario, Canada manufacturing site

during December 10 - 19, 2008 uncovered significant CGMP violations and the

failure of your quality unit to carry out its responsibilities. This

resulted in issuance of a Warning Letter on June 25, 2009. In your response

to the FDA-483 you reported that your Etobicoke and Signet facilities are

managed by the same quality unit. The violations found during the July -

August 2009 inspection at Signet Drive, Ontario are an indication that your

quality unit continues to fail to perform its responsibilities regarding

control and review, and to release products that meet specifications. Your

response to the FDA-483 is inadequate in that it does not address the

inability of your quality unit to conduct adequate investigations, determine

the root cause, or establish adequate preventive and corrective actions for

the problems found. Please provide a corrective action plan that describes

your procedures, corrective and preventive actions and controls to ensure

product quality. This plan should also include a comprehensive retrospective

review of your raw material suppliers, equipment adequacy, cleaning and

maintenance procedures implemented to ensure that all products produced and

released by your quality unit meet specifications.

4. Your firm fails to have an adequate equipment cleaning and maintenance

procedure or program to prevent contamination that would alter the safety,

identity, strength, quality, or purity of the drug product beyond other

established requirements [21 C.F.R. § 211.67(a)].

For example, a field alert report (FAR) involving Eplerenone Tables (ANDA

78-482) reported the presence of powder residues during a preventive

maintenance check of the (b)(4) (asset #5001-PR31-(b)(4)). Based on your

investigation, the root cause was determined to be an inadequate cleaning

procedure because the procedure did not provide for complete disassembly of

the (b)(4) lines, as well as use of the clean-in-place system. Your

investigation also concluded that your preventive maintenance program was

not robust enough to detect the potential contamination. In December 2009,

two other FARs were reported regarding the same situation. Although the

first notification about cross-contamination was in September 2009, it was

not until December 2009 that other equipment and products were implicated

because of cross-contamination. As part of this investigation, you used

placebo batches (instead of product) in a study to determine if the cleaning

procedure was adequate and the product was fit for release. This study is

inadequate in that it did not reproduce the scenario and conditions that

specifically lead to the problem nor predict the level of the contamination

that may exist. Your cleaning procedure should be robust enough to ensure

that no residue from previous lots remains in the manufacturing equipment.

Furthermore, a FAR investigation initiated on October 2, 2009, for Diltiazem

capsules manufactured in (b)(4)), indicated that a powder residue was

present on some of the (b)(4) units used in your facility. The (b)(4)

piping, connected to the (b)(4) to provide (b)(4) to the units, came in

contact with the product. Your investigation is inadequate because it does

not provide assurance that the powder particles in (b)(4) did not

contaminate the product manufactured in this equipment. Your actions did not

include a global approach of corrective actions in that all (b)(4) were not

examined for powder residue.

Additionally, an investigation into a FAR initiated on December 8, 2009, for

Clonazepan tablets (0.5 mg, 1 mg, and 2 mg) in 100 and 500 bottles, revealed

that foreign materials were found in the (b)(4) (asset #750) above the

(b)(4) of the (b)(4) (asset #5001-PR25-KE209). Your investigation indicated

that the presence of the foreign material was due to incorrect sizing of the

(b)(4) and seal during equipment modification. Also, you indicated that the

contaminated products were Clonazepam tablets and (b)(4) capsules. This

investigation is inadequate because it did not include when the modification

occurred, or identify all the lots manufactured with the (b)(4) since the

modification. The investigation report also fails to include whether the

modification occurred in other (b)(4) used in your facility, or if the other

(b)(4) were examined for similar issues. The FAR only included Clonazepam

tablets lots. It did not list the lots related to (b)(4) capsules.

We are concerned about your inadequate preventive maintenance and cleaning

procedures and your failure to conduct a timely investigation into all

equipment and products potentially affected by the deviations.

FIELD ALERT REPORTING VIOLATIONS

The NDA/ANDA Field Alert reporting requirements in 21 C.F.R. §

314.81(b)(1)(i) and (ii), effective since May 23, 1985, require holders of

NDAs and ANDAs to submit certain information about distributed drug products

to the appropriate FDA district office within three working days of receipt

by the applicant. The intent of the 21 C.F.R. § 314.81(b)(1) regulation is

to establish an early warning system so that significant problems are

brought to the Agency's attention by applicant holders in order to prevent

potential safety hazards from drug products already in distribution and also

to prevent potential safety hazards with drug products manufactured in the

future. Field Alert Reports must be submitted for confirmed and unconfirmed

problems meeting the definition of the regulation within three working days

of becoming aware of the problem.

In addition to the aforementioned CGMP violations, your firm is in violation

of the Field Alert reporting requirements set forth in 21 C.F.R. §

314.81(b)(1)(i) and (ii). For example, during November and December 2009,

your firm submitted two FARs due to contamination found in your

manufacturing equipment. Your quality unit was notified of one of the two

FARs that pertains to Eplerenone tablets (ANDA 78-482) on September 16,

2009. However, the FAR was not submitted to FDA until November 20, 2009. The

second FAR, pertaining to the (b)(4) (asset #5001-PR29-(b)(4)) equipment

used in manufacturing room (b)(4), was submitted to FDA on December 7, 2009.

However, your quality unit was aware of this information on November 26,

2009.

We remain concerned with the continuing CGMP violations demonstrated at your

facilities and failure to report FAR related events within three days of

becoming aware of a problem. Please include in your written response the

corrective action you plan to take regarding distributed products

manufactured at these facilities that may be affected by the violations.

The violations cited in this letter are not intended to be an all-inclusive

statement of violations that exist at your facility. You are responsible for

investigating and determining the causes of the violations identified above

and for preventing their recurrence and the occurrence of other violations.

If you wish to resume shipping products to the United States, it is the

responsibility of your firm to ensure compliance with all U.S. standards for

CGMP and all applicable U.S. laws and regulations.

Until all corrections have been completed and FDA has confirmed corrections

of the violations and your firm's compliance with CGMP, this office will

recommend withholding approval of any new applications or supplements

listing your firm as a drug product manufacturer. In addition, failure to

correct these violations will result in FDA continuing to deny entry of

articles manufactured at Apotex Inc., Toronto, Canada into the United

States. Because your firm is currently under Import Alert, the articles are

subject to refusal of admission pursuant to section 801(a)(3) of the Act [21

U.S.C § 381(a)(3)], in that, the methods and controls used in their

manufacture do not appear to conform to Current Good Manufacturing Practice

within the meaning of section 501(a)(2)(B) of the Act [21 U.S.C §

351(a)(2)(B)].

Within fifteen working days of receipt of this letter, please notify this

office in writing of the specific steps that you have taken to correct

violations. Include an explanation of each step being taken to prevent the

recurrence of violations and copies of supporting documentation. If you

cannot complete corrective action within fifteen working days, state the

reason for the delay and the date by which you will have completed the

correction. Please identify your response with FEI #3002906944.

If you have questions or concerns regarding this letter, contact Maan

Abduldayem, Compliance Officer, at the below address and telephone number.

U.S. Food and Drug Administration

Center for Drug Evaluation and Research

Division of Manufacturing and Product Quality

International Compliance Branch

White Oak, Building 51

10903 New Hampshire Ave

Silver Spring, MD 20993

Tel: (301) 796-3916

Fax: (301) 847-8741

Sincerely,

Teddi Lopez for

/Richard L. Friedman/

Richard L. Friedman

Director

Division of Manufacturing and Product Quality

Office of Compliance

Center for Drug Evaluation and Research

=========================================================================================

GAMING THE SYSTEM IS MANIPULATION OR EXPLOITATION OF THE RULES DESIGN TO GOVERN A GIVEN SYSTEM IN AN ATTEMPT TO GAIN AN ADVANTAGE OVER OTHER USERS.

THE UGLIEST OF ALL SUPPORTED BY MENTIONED IS USE AND ABUSE OF THE LAW AGAINST WHOLE SEGMENT OF SOCIETY / POPULATION IN ORDER TO BE ABLE TO SUBORDINATE THEM TO MAKE PEOPLE BLINDLY SUBJECT THEMSELVES TO SOMETHING WITHOUT ENOUGH OF A "KLINICAL SCRUTINY / CLINICAL TRIALS " TO BE ABLE TO INDEPENDENTLY SAY THAT " PRODUCT " IS ENOUGH GOOD FOR HUMAN COMPETITION, THAT WILL NOT CAUSE SHORT OR / AND LONG TERM PROBLEMS "SIDE EFFECTS OF SYSTEMS " THAT WILL NOT PROMPT UNFORSEEN / IRREVERSIBLE D.N.A. CHANGES etc.

AN ADVANTAGE OVER OTHER USERS.

I INSURED CANADIAN, WORKING FOR A LONG TIME FOR PREMIER CANADIAN EMPLOYER, WHEN I NEEDED DESPERATELY IMMEDIATE HELP DUE TO EMPLOYER's YEARS OF CONSCIOUS CRIMINAL NEGLIGENCE , HELP WAS NOT ANYWHERE TO BE FOUND. GOVERNMENT AGENCIES WHICH SUPPOSED TO BE OF HELP / ASSISTANCE, TURNED OUT TO BE THE WORST PREDATORS, ENEMY " ENEMY WITHIN". I HORRIBLY SICK PERSON SUFFERING FROM INFLICTED TERRIBLE SIDE EFFECT (MOSTLY SYNTHETIC CHEMICALS / LETHAL ) , PRODUCED MASSIVELY IN SECRECY BY EMPLOYER, WITHOUT ANY PERMITS, IN FACILITY NOT READY FOR / UNDER BIGEST IN ONTARIO CONSTRUCTION etc. I NEEDED ALL HELLP I CUD GET AND MORE UNTIL TODAY AND PENDING I WAS DEPRIVED OF ALL OF HELP / ASSISTANCE.

My ex- employer Torpharm / Apotex, Government Agencies involved with my Claim, Provincial / Federal Governments etc. defrauded me ( extremely impaired on toxic / lethal mostly synthetic products ) employee and processed only half of my entitlements for ALL my payments ( C.P.P., Unemployment etc. ) forcing me into years of extreme poverty. ( 19 + YEARS and pending ).

Canada, U.S.A. Law is saturated with a lot of Regulations, Directives and yes by LAW - INTRODUCED BILLS about how particular Jurisdiction, Government / Branch MUST act dealing with the General Public. In Canada a variety of Governments passed by the BILLS detailed Roles telling / informing everyone what is the Law and associated time limitations if any so everyone obeys by the book etc. So for instance in Ontario Bill - 107 was passed by the Government of Premier McGuinty and it became a LAW!

I HOLD ADDITIONALLY ALL DEALING WITH MY CLAIM / CASE PERSONALLY, CRIMINALLY AND SEVERLY RESPONSIBLE / LIABLE FOR ALL MY SUFFERS, TORTURES, DISABILITIES, IMPRIZONMENT AND ALL OF WHAT I ALLEAG (Bill - 107, Bill - 45, Bill - 168, Bill -133, C-27, etc. ......:) etc.!

ALL PEOPLE ACTING IN MY CASE ON BEHALF OF EX - EMPLOYER AND / OR GOVERNMENT AGENCIES MISREPRESENTED THEMSELVES, ACTED ON BEHALF OF EX - EMPLOYER AND / OR ILLEGALLY ON THEIR OWN ON BEHALF OF ANY OF GOVERNMENT AGENCIES AND DID SO ON THEIR OWN terms AGAINST LAW AND AGAINST THE EMPLOYER's INFORMATION CONTAINED IN SEPARATION LETTER ON FRONT PAGE ADMITTING TO CRIMES AND TO EX - EMPLOYER's GOOD WILL, CONDITIONS OF EMPLOYER's TO BE OBSERVED FULFILMENT OF MENTIONED INTO MY BENEFIT, BENEFIT OF A PERSON ILLEGALLY UNKNOWINGLY PRODUCING END VERY NEGATIVELY IMPACTED BY / AFFECTED BY URGENCY OF THE SITUATION. WITH UNKNOWN SIDE EFFECTS ALREADY HEAVILY EFFECTING IMPAIRED EMPLOYEE NEEDED INSTANT MEDICAL ATTENTION. PEOPLE / EMPLOYEES COMMITTED FRAUD FOR 19+ YEARS AND PENDING IGNORING THE URGENCY OF THE SITUATION / CONDITIONS.

"TorPharm Inc. will provide you with all of your current employment benefits until the end of six weeks from the date of this letter , with your Extended Health and Dental benefit coverage then continuing until May 4 2004 , or until such time as you secure employment with benefit coverage elsewhere etc. TorPharm Inc. will offer you employment services with Right Axmith, help of Mike Sostaric , Manager , Human Resources etc. "

That is an example of how an exceptional long term employee, impaired by side effects of lethal illegal products he was forced to work with , was treated after many years being forced to work on those products in confidentiality etc."

THEN I WAS DEPRIVED OF EVERYTHING UNTIL NOW AND PENDING. I DO NOT DESERVE THAT.

MY TERMINATION LETTER CONTAINS EX - EMPLOYER's COMMITMENT TO LOOK AFTER ME, SEVERELY IMPAIRED LONG TERM EXCEPTIONAL EMPLOYEE DUE TO EMPLOYERS CRIMINAL NEGLIGENCE FOR AS LONG AS IT TAKES, COVERING WHAT NEEDS TO BE COVERED. I DID NOT NEED TO CONTACT CRIMINAL CHARACTERS IN ALL OF THOSE AGENCIES OR BE SUBJECTED TO ANY OF THEIR "PERVERTED" BUREAUCRATIC WAYS FOR 19 + YEARS AND PENDING WHILE MY EMPLOYER WAS PERMANENTLY ABSENT AT THE WORKPLACE, PLAYING "LOBBYIST" IN SOMEONE's OFFICE INSTEAD OF BEING AT OWN PLACE OF WORK etc. I SUPPOSED TO BE TAKEN CARE OF ME BY MY EX- EMPLOYER FOR AS LONG AS IT TAKES WITHOUT ANY PARTICIPATION OF THIRD PARTY's INVOLVEMENT TO GRATIFY THEMSELVES A SPECIALLY FOR SUCH A LONG PERIOD OF TIME DEPRIVING ME OF EVERYTHING FOR PERMANENT OCCURRENCE AND CAUSING SO MUCH DAMAGE TO ME AND TO SO MANY.

MY EX - EMPLOYER DESTROYED MY HEALTH BY CRIMINAL NEGLIGENCE AND WITH HELP / PARTICIPATION OF HIS UNABLERS IN GOVERNMENT AGENCIES WCHICH I LIST ABOWE DID DEPRIVE ME AND MANY OF EVERYTHING FOR 19 + YEARS AND PENDING. I AM AWAITING CORRECTION OF HIS ACTIONS.

*************************************************************************************************************************************

THEN I WAS DEPRIVED OF EVERYTHING UNTIL NOW AND PENDING. I DO NOT DESERVE THAT.

IN EX - EMPLOYER's LETTER KOMITMENTS:

"TorPharm Inc. will provide you with all of your current employment benefits until the end of six weeks from the date of this letter, with your Extended Health and Dental benefit coverage then continuing until May 4 2004, or until such time as you secure employment with benefit coverage elsewhere etc. TorPharm Inc. will offer you employment services with Right Axmith, and help of Mike Sostaric , Manager, Human Resources etc. "

That is an example of how an exceptional longterm employee, impaired by side effects of lethal illegal products he was forced to work with, was treated after many years being forced to work on those products in confidentiality etc."

THEN I WAS DEPRIVED OF EVERYTHING UNTIL NOW AND PENDING. I DO NOT DESERVE THAT.

VERY IMPAIRED ON COMPANY's PRODUCTS, EXCEPTIONAL, LONG TERM, WORKING IN CONFIDENTIALITY ON LETHAL ILLEGAL PRODUCTS, KEEPING BY EMPLOYER IN STRICT CONFIDENTIALITY, WITHOUT PERMITS / NAMES / NATURE. EXCEPTIONAL / CAPABLE EMPLOYEE WAS TERMINATED WITH OUT "JUST CAUSE" BY EMPLOYER AND DEFRAUDED AND AS IN COUNT LESS COMMUNICATIONS , SUBJECTED TO TERROR, TORTURE, IMPRISONMET AND AS ADMITED BY EX - EMPLOYER FOR 19 + YEARS AND PANDING. INSTEAD OF BEING TREATED TIMELY / PROPERLY, WITH PROPER / WORKING MEDICATION / THERAPY I WAS MISTREATED BY COMPANIES AND EVERY ONE INVOLVED IN THE CASE / PROCESS FOR 19 + YEARS AND PENDING. PEOPLE DEALING WITH ME SHOULD PROVIDE ME WITH HELP RIGHT AWAY NOT SUBJECTED ME FOR 19 + YEARS TO HEAL AND PENDING!

ALL LISTED INDIVIDUALS ACTED MALICIOUSLY, VINDICTIVELY TO CAUSE A LOT OF VINDICTIVE PROBLEMS INSTEAD OF RAPID CURE.

MY TERMINATION LETTER CONTAINS EX - EMPLOYER's COMMITMENT TO LOOK AFTER ME, SEVERELY IMPAIRED LONG TERM EXCEPTIONAL EMPLOYEE DUE TO EMPLOYERS CRIMINAL NEGLIGENCE FOR AS LONG AS IT TAKES, COVERING WHAT NEEDS TO BE COVERED. I DID NOT NEED TO CONTACT CRIMINAL CHARACTERS IN ALL OF THOSE AGENCIES OR BE SUBJECTED TO ANY OF THEIR "PERVERTED" BUREAUCRATIC WAYS FOR 19 + YEARS AND PENDING WHILE MY EMPLOYER WAS PERMANENTLY ABSENT AT THE WORKPLACE, PLAYING "LOBBYIST" IN SOMEONE's OFFICE INSTEAD OF BEING AT OWN PLACE OF WORK etc. I SUPPOSED TO BE TAKEN CARE OF ME BY MY EX- EMPLOYER FOR AS LONG AS IT TAKES WITHOUT ANY PARTICIPATION OF THIRD PARTY's INVOLVEMENT TO GRATIFY THEMSELVES A SPECIALLY FOR A PERIOD OF A SUCH LONG TIME DEPRIVING ME OF EVERYTHING FOR PERMANENT OCCURRENCE AND CAUSING SO MUCH DAMAGE TO ME AND TO SO MANY.

MY TERMINATION LETTER CONTAINS EX - EMPLOYER's COMMITMENT TO LOOK AFTER ME, SEVERELY IMPAIRED LONG TERM EXCEPTIONAL EMPLOYEE DUE TO EMPLOYERS CRIMINAL NEGLIGENCE FOR AS LONG AS IT TAKES, COVERING WHAT NEEDS TO BE COVERED. I DID NOT NEED TO CONTACT CRIMINAL CHARACTERS IN ALL OF THOSE AGENCIES OR BE SUBJECTED TO ANY OF THEIR "PERVERTED" BUREAUCRATIC WAYS FOR 19 + YEARS AND PENDING WHILE MY EMPLOYER WAS PERMANENTLY ABSENT AT THE WORKPLACE, PLAYING "LOBBYIST" IN SOMEONE's OFFICE INSTEAD OF BEING AT OWN PLACE OF WORK etc. I SUPPOSED TO BE TAKEN CARE OF BY ME BY MY EX- EMPLOYER FOR AS LONG AS IT TAKES WITHOUT ANY PARTICIPATION OF THIRD PARTY's INVOLVEMENT TO GRATIFY THEMSELVES A SPECIALLY FOR SUCH A LONG TIME DEPRIVING ME OF EVERYTHING FOR PERMANENT OCCURRENCE AND CAUSING SO MUCH DAMAGE TO ME AND TO SO MANY.

APOTEX's EXCUSE FOR A CRIMINAL BEHAVIOUR WAS AMONGST OTHER THINGS A CONSTANT "TALENT SEARCH" BY Mr. W. RON DAVIDSON, CHRF - VICE PRESIDENT, HUMAN RESOURCES, JACK KEY, PRESIDENT - COO, APOTEX, BERNARD SHERMAN, CHAIRMAN @ CEO APOTEX INCORPORATED WITH THEIR ENABLERS / MAFIA TEAM STRATEGICALLY LOCATED IN KEY GOVERNMENT AGENCIES AND IN A COMMUNITY REGARDLESS ON PREVIOUS / PRESENT ASSOCIATIONS. PEOPLE, COMMUNITY, HEALTH PRODUCTS CONSUMERS, EMPLOYES DID NOT COUNT DESPITE DIRECT / INDIRECT HEALTH CONDITIONS CAUSED BY TORPHARM / APOTEX.

Apotex with own enablers / "DANGEROUS OFFENDERS" located strategically in Government Agencies, Civil Institutions and every were else of strategic value, did severely impair me on illegally obtain and processed products, then severely incapacitated me for 19 + years and pending, then they did defraud me, my family and people around me of everything for almost some 20 years and pending etc.

ALL THOSE ENABLERS / "DANGEROUS OFFENDERS" RESYSTED CORRECTIVE ACTION FOR SO LONG AND WERE PRAYING UPON / ON MY ILLS, WERE TAKING ADVANTAGE OF A DISABLED ON THE JOB PERSON / ONTARIAN / CANADIAN DUE TO CRIMINAL / METHODICAL NEGLIGENCE.

All those characters from my list (not full ) were perfectly aware of their criminal / conscious activity because they were part of the criminal activities and they were purposely, actively and consciously ignoring ex - employer's commitments / obligations as being a part of it. They all ignored it having it in front of themselves at all the time and being aware that they ignor processing disabled on the job, havely incapacitated on the job by the illegal products, havely impaired , disabled person and they did it for 20+ years and pending despite it. They did it consciously knowing very well that they can NON successfully process it on their own and by being part of a criminal circle they have to commit crime covering up for my ex - employer - TorPharm / Apotex.

All those People regardless of status / place in Society, Civil / Profesional place in life or level of individual education did commit fraud against me individually and collectively, reneging on collective and personal duty to protect me contributing a great deal a Canadian worker individually / collectively being challenged and protect me from individual / collective harm on many levels. So big time medical, financial, economic and many, many more factors were totally neglected / ignored and forgotten placing me in position without any and all parallel for 20 + YEARS AND PENDING, leaving me without any choice whatsoever for so long. More about it etc.......:).

I am totally disabled and everyone not only ignores it but also there is not any help.

VICTIM