FDA WARNING_LETTER - Apotex Inc. - October 26, 2012

The FDA issued a Warning Letter to Apotex Inc. following inspections from August 13-24, 2012, at their Toronto facility, and October 18-26, 2012, at their Richmond Hill facility, identifying significant violations of CGMP regulations (21 CFR Part 210 and 211). These violations render their drug products adulterated.

At the Toronto facility, violations included: 1. Failure to prevent microbiological contamination of sterile drug products (21 CFR 211.113(b)), specifically inadequate unidirectional airflow studies for aseptic filling lines and failure to establish maximum holding times for media fill vials prior to incubation. 2. Failure to thoroughly investigate unexplained discrepancies or batch failures (21 CFR 211.192), evidenced by releasing partial batches without specific criteria or adequate investigations, and repeat violations of this nature. This also raised concerns about process validation and root cause analysis for issues like tablet defects. 3. Failure to ensure laboratory records included complete data (21 CFR 211.194(a)), such as a microbiologist inaccurately reporting environmental monitoring results.

At the Richmond Hill facility, violations included: 1. Failure to thoroughly investigate batch failures (21 CFR 211.192), specifically not recalling all in-expiry products manufactured on a line that produced a failed sterility test batch