Cadila Healthcare Limited – FDA Warning Letter, Feb 3, 2011

On June 21, 2011, the FDA issued a Warning Letter to Cadila Healthcare Limited following a January 17 - February 3, 2011 inspection. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Incomplete Laboratory Records (21 CFR § 211.194):** * Microbiologists reported "nil" for plates with 1 CFU/m3, which should have triggered an investigation based on the action limit. * Incorrect identification of microbial growth on settle plate MS 4 as "typical flora" when it was atypical, preventing further required identification. * The firm's corrective action plan for data integrity was deemed insufficient, as it did not improve on existing practices and lacked proper identification of microbiologists on revised forms. * Discrepancies in training attendance for microbiologists were noted, and comprehensive retraining documentation for all employees was requested.

2. **Inadequate Procedures to Prevent Microbiological Contamination (21 CFR § 211.113(b)):** * Insufficient personnel monitoring: Gowns were monitored only (b)(4) per week, and gloves only at the (b)(4) of