FDA WARNING_LETTER - Cadila Healthcare Limited - May 03, 2019

The FDA issued a Warning Letter to Cadila Healthcare Limited following an inspection from April 22 to May 3, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Equipment Cleaning (21 CFR 211.67(a)):** Non-dedicated equipment, specifically a (b)(4), was found with residues of different products after cleaning, leading to cross-contamination. The firm's subsequent testing confirmed active ingredient presence in reserve samples and led to a recall. The firm's rationale for uniform distribution of contamination was deemed scientifically unsound, and their response was insufficient regarding the origin and detection of contamination. 2. **Insufficient Investigation of Discrepancies (21 CFR 211.192):** Investigations into failures during periodic requalification of a (b)(4) were inadequate. Recurrent failures, including microbiological growth in biological indicators, led to a recall of a (b)(4) Injection batch due to lack of (b)(4) assurance. The firm failed to adequately identify the root cause or extend CAPA to other affected products. 3. **Failure to Prevent Microbiological Contamination (21 CFR 211.113(b)):** Operators exhibited poor aseptic practices, and the stopper chute design created turbulence, promoting contamination. Smoke studies were deficient, lacking simulation of