Wockhardt Limited – FDA Warning Letter, Jul 31, 2013

The FDA issued a Warning Letter to Wockhardt Limited following simultaneous inspections of their Chikalthana and Waluj, India, facilities from July 22-31, 2013. The inspections revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Incomplete Laboratory Records (21 CFR 211.194(a)):** Both facilities performed "trial" HPLC analyses, often deleting data, including out-of-specification results, before official testing. This practice raises serious concerns about data integrity and manipulation, with some "trial" injections appearing to use actual samples disguised as standards. 2. **Inadequate Computer System Controls (21 CFR 211.68(b)):** QC laboratory instruments were stand-alone, allowing deletion of raw electronic data without audit trails or backups. Analysts used shared user IDs and passwords, enabling unauthorized data manipulation. 3. **Failure to Follow Production and Process Control Procedures (21 CFR 211.100(b)):** At Chikalthana, operators performed in-process tablet testing without contemporaneous documentation, recording weights from memory in a separate room. A production balance was also found unlevel.