FDA WARNING_LETTER - Cadila Healthcare Limited - December 06, 2014

The FDA issued a Warning Letter to Cadila Healthcare Limited following inspections in August-September and December 2014 at two facilities in Ahmedabad, India (FEI 3002984011 and FEI 3006595385). 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 drugs adulterated.

At FEI 3002984011, violations included inadequate investigation of out-of-specification (OOS) results for warfarin sodium, a narrow therapeutic index drug, with recurring quality problems despite previous inspections and a recall. The firm also failed to adequately investigate consumer complaints regarding product mix-ups, did not file Field Alert Reports (FARs) promptly, and had deficient complaint handling procedures.

At FEI 3006595385, violations included failure to establish written procedures to control API processing steps, leading to repeated failing results for related compound analysis without root cause identification. The firm also failed to control computerized systems to prevent unauthorized data access or changes, with evidence of deleted electronic records and shared login credentials. Additionally, employees used "unofficial notebooks" for CGMP activities, and duplicate records with discrepancies were found, indicating poor documentation practices and a lack of corporate quality assurance.

Cadila's responses were