FDA WARNING_LETTER - Aarti Drugs Limited - November 05, 2012

The FDA issued a Warning Letter to Aarti Drugs Limited following inspections of their pharmaceutical manufacturing facilities in Tarapur, India, from October 25-30, 2012, and November 1-5, 2012. The inspections revealed significant violations of CGMP regulations for finished pharmaceuticals (21 CFR Parts 210 and 211) and deviations from CGMP for Active Pharmaceutical Ingredients (APIs), rendering their APIs adulterated.

Key violations included: 1. **Failure to record all quality activities at the time they are performed:** Instances were observed where batch record entries and QC analysis completion times were recorded before the activities occurred. Original batch record pages were replaced, and raw data was initially recorded on scrap paper and then destroyed. 2. **Failure to review and investigate production and QC laboratory deviations:** Over 30 power outages in 2012 at one facility and over 100 at another were not investigated for their impact on product quality or stability samples. Laboratory equipment failures and atypical peaks in related substance assay results for API batches were also not properly investigated. 3. **Failure to maintain laboratory control records with complete data:** HPLC processing methods lacked defined procedures, and re-integrations were performed until results appeared "good" without proper documentation or audit trails. Raw data for standard and sample preparations were not retained, and chromatography raw data lacked run sequences or processing methods. The audit trail function for