Aurobindo Pharma Limited – FDA Warning Letter, Dec 22, 2010

The FDA issued a Warning Letter to Aurobindo Pharma Limited, Units III and VI, following inspections in September and December 2010, respectively. The inspections revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drugs adulterated under 21 U.S.C. § 351(a)(2)(B).

For Unit VI, violations included incomplete laboratory records (21 C.F.R. § 211.194), such as falsified microbial plate counts and destruction of evidence, a repeat violation from 2007. Missing microbial plates (22% of personnel samples) and questionable environmental monitoring data (no alert/action levels reported despite visible growth during inspection) were also cited. The firm lacked adequate written procedures to prevent microbiological contamination (21 C.F.R. § 211.113(b)), with insufficient environmental monitoring SOPs and sampling locations. Additional deficiencies included discrepancies in handling extra plates, unsampled stopper handling devices, and failure to control batch record pages.

For Unit III, the firm failed to thoroughly investigate batch failures and components not meeting specifications (21 C.F.R. § 211.192). Inadequate investigations into Field Alert Reports (FARs) regarding product/labeling mix-ups (e.g., wrong tablets in bottles) were noted, with repeated attribution to "human error" without robust corrective