FDA WARNING_LETTER - Wockhardt Limited - March 22, 2013

This FDA Warning Letter, dated July 18, 2013, addresses Wockhardt Limited's pharmaceutical manufacturing facility in Aurangabad, India, following an inspection from March 18-22, 2013. The FDA identified significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211) and documented that the firm withheld truthful information, and delayed and limited the inspection. These violations render drug products adulterated under Sections 501(a)(2)(B) and 501(j) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Repeatedly delaying, denying, or limiting inspection:** Examples include a QA Officer providing incomplete raw data records, a QC Analyst dumping vial contents to prevent observation, a Production Head providing inaccurate information about unofficial batch records, the Vice President of Manufacturing misrepresenting the operational status of an aseptic filling line, and delaying provision of requested QC data until the inspection's final day. 2. **Failure to prepare complete batch production and control records (21 CFR 211.188(b)):** Unofficial, torn batch records for injectable products showed defect rates exceeding specifications (up to 14%), which should have triggered investigations, but none were performed. Official records for these batches falsely stated compliance. 3. **Failure to ensure laboratory records included complete