FDA WARNING_LETTER - Apotex Research Private Limited - July 01, 2014

The FDA issued a Warning Letter to Apotex Research Private Limited (ARPL) following a June 23 - July 1, 2014 inspection, identifying significant CGMP violations, rendering drug products adulterated. The firm's July 22, 2014 response and subsequent correspondence were deemed insufficient.

Violations included: 1. **Incomplete Laboratory Records (21 CFR 211.194(a)):** ARPL performed "trial" testing, disregarded failing results, and reported only passing data. Examples included unreported out-of-specification (OOS) impurity results for (b)(4) and (b)(4) Tablets and selective reporting of HPLC impurity data for (b)(4) mg Tablets. The firm's explanations for retesting were inadequate, and investigations were not extended to all electronic systems. 2. **Inadequate Computer System Controls (21 CFR 211.68(b)):** Unauthorized folders like "WASH" were created on laboratory systems, containing uninvestigated sample injections with OOS results. The firm's focus on intent rather than the seriousness of disregarding failing results and retesting without investigation was noted. 3. **Failure to Prevent Objectionable Microorganisms (21 CFR 211.113(a)):** Missing in-progress microbiological test plates for various products, water, and media growth promotion samples were