Apotex Inc. – FDA Warning Letter, Aug 14, 2009

The FDA issued a Warning Letter to Apotex Inc. following a July 27-August 14, 2009, inspection of their Toronto, Ontario, Canada facility, revealing significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Parts 210 and 211) and failure to submit NDA Field Alert Reports (FARs) as required (21 CFR § 314.81(b)(1)). These violations render their drug products adulterated.

The inspection uncovered repeat violations from a December 2008 inspection at their Etobicoke site, indicating systemic quality and production control deficiencies. Both facilities were placed under import alert on August 28, 2009, leading to detention of all finished drug products without physical examination. Apotex voluntarily recalled approximately 659 batches.

Specific violations include: 1. **Quality Control Unit Failures (21 CFR § 211.22(d)):** Release of drug products manufactured with contaminated Active Pharmaceutical Ingredients (APIs) (e.g., Cetirizine HCl, Metformin HCl) and repackaging of products that failed Acceptable Quality Level (AQL) tests without scientific rationale or assessing quality impact. 2. **Inadequate Production and Process Controls (21 CFR § 211.100(a)):** Failure to assure drug product identity, strength,