Drug factory · FDA FEI 3002906944

Apotex Inc.

4100 Weston Road, Toronto, Canada

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

May 11, 2015 inspection

• Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
  Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
• Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
  Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
• Late submission of quarterly safety reports 21 CFR 314.80(c)(2)
  Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.
• Late submission of quarterly safety reports 21 CFR 314.80(c)(2)
  Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.

Aug 20, 2013 inspection

• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
• Annual visual exams of drug products 21 CFR 211.170(b)
  Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
• Annual visual exams of drug products 21 CFR 211.170(b)
  Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
• Procedures to be written and followed 21 CFR 211.198(a)
  Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
• Procedures to be written and followed 21 CFR 211.198(a)
  Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.

Aug 24, 2012 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Actual vs. theoretical yields not determined 21 CFR 211.103
  Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of processing of the drug product.
• Actual vs. theoretical yields not determined 21 CFR 211.103
  Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of processing of the drug product.
• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
• Written procedures not followed 21 CFR 211.122(a)
  Written procedures for the examination of packaging and labeling materials are not followed.
• Written procedures not followed 21 CFR 211.122(a)
  Written procedures for the examination of packaging and labeling materials are not followed.
• Destruction of excess labels with lot numbers 21 CFR 211.125(d)
  Excess labeling bearing lot or control numbers is not destroyed.
• Destruction of excess labels with lot numbers 21 CFR 211.125(d)
  Excess labeling bearing lot or control numbers is not destroyed.
• Expiration date lacking 21 CFR 211.137(a)
  Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
• Expiration date lacking 21 CFR 211.137(a)
  Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
• Accurate reproduction 21 CFR 211.188(a)
  The batch production and control records are deficient in that they are not an accurate reproduction of the appropriate master production or control record.
• Accurate reproduction 21 CFR 211.188(a)
  The batch production and control records are deficient in that they are not an accurate reproduction of the appropriate master production or control record.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• GMP Training Frequency 21 CFR 211.25(a)
  GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
• GMP Training Frequency 21 CFR 211.25(a)
  GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
• Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
  Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
• Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
  Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
• Status of Each Lot Identified 21 CFR 211.80(d)
  Each lot of was not appropriately identified as to its status in terms of being quarantined, approved or rejected.
• Status of Each Lot Identified 21 CFR 211.80(d)
  Each lot of was not appropriately identified as to its status in terms of being quarantined, approved or rejected.
• Certificates of Testing (Containers, Closures) 21 CFR 211.84(d)(3)
  Certificates of testing of containers and closures are accepted in lieu of testing without a visual identification and establishing the reliability of the supplier's test results through appropriate validation of the test results at appropriate intervals.
• Certificates of Testing (Containers, Closures) 21 CFR 211.84(d)(3)
  Certificates of testing of containers and closures are accepted in lieu of testing without a visual identification and establishing the reliability of the supplier's test results through appropriate validation of the test results at appropriate intervals.

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