FDA WARNING_LETTER - Sun Pharmaceutical Industries Limited - Karkhadi - November 16, 2013

On May 7, 2014, the FDA issued a Warning Letter to Sun Pharmaceutical Industries Limited - Karkhadi, India, following a November 13-16, 2013, inspection. The inspection 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 products adulterated.

Key violations include: 1. **Incomplete Laboratory Records and Data Manipulation:** The firm failed to maintain complete raw data for analyses, including sample identification, full raw data (graphs, electronic files), test methods, calculations, and proper sign-offs. "Unofficial testing" was frequently performed, with results discarded and "official" passing results reported. Examples include deleted HPLC and GC chromatograms (5,301 deleted HPLC files found), some showing out-of-specification (OOS) results that were not investigated. 2. **Failure to Control Computer Systems:** The GC instrument software allowed file deletion without an audit trail, enabling data manipulation and overwriting of deleted files with identical names, making traceability impossible. 3. **Failure to Maintain Records:** Approximately 10 waste bags contained torn or destroyed CGMP records, including calibration checks, CAPA records (some without official copies), and preventive maintenance forms. This indicates a lack of oversight and systemic record destruction. 4.