Apotex Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to thoroughly investigate any unexplained discrepancy or 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 CFR 211.192).

Passage 2

Your firm failed to conduct adequate investigations for your **(b)(4)** solutions, **(b)(4)** solutions, and **(b)(4)** spray drug products distributed to the U.S. market. For example, you did not properly investigate critical equipment failures and container-closure integrity issues to evaluate root causes or assess impact on other potentially affected batches in a timely manner.

Passage 3

You failed to adequately clean, decontaminate, and maintain your **(b)(4)** used for aseptic drug product manufacturing. For example, our investigator observed multiple instances of deterioration and damage to the **(b)(4)** used for manufacturing sterile **(b)(4)** drug products. These instances of deterioration and damage were not adequately addressed through your cleaning, decontamination, and maintenance programs. For example, our investigator observed:

Passage 4

Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).