FDA 483 - Cadila Healthcare Limited - March 01, 2017

FDA investigators conducted an inspection of Cadila Healthcare Ltd. in Baddi, India, from March 1 to March 17, 2017. The inspection revealed several significant deficiencies in the facility's quality control and manufacturing processes, leading to the issuance of a Form 483 with multiple observations.

One key observation noted that the quality control unit lacked adequate procedures to ensure the integrity and accuracy of data. Specifically, the firm's audit trail review for chromatographic data was found to be insufficient, with no documented evidence of review for data generated by the Empower 3 software. This raises concerns about data integrity and the reliability of analytical results used for batch release.

Another critical finding involved the firm's handling of out-of-specification (OOS) results. The investigation into an OOS result for related substances in a stability sample of Esomeprazole Magnesium Delayed-Release Capsules was deemed inadequate. The firm failed to identify a root cause for the OOS result, and the retesting performed was not justified, leading to an invalidation of the initial OOS result without proper scientific rationale. This indicates a weakness in their OOS investigation procedures and a potential risk of releasing non-conforming products.

Furthermore, the inspection revealed that the firm's procedures for cleaning and maintenance of equipment were deficient. Specifically, the cleaning validation for certain manufacturing equipment was not adequately established or followed, potentially leading to cross-contamination of products.

These observations indicate a