FDA WARNING_LETTER - GPT Pharmaceuticals Private Ltd - June 28, 2019

The FDA inspected GPT Pharmaceuticals Pvt. Ltd. in Hyderabad, India, from June 24-28, 2019, identifying significant CGMP violations, rendering their drug products adulterated.

Key violations include: 1. **Quality Control Unit Failure (21 CFR 211.22):** The Quality Unit (QU) failed to adequately oversee manufacturing, specifically by not properly investigating Out-of-Specification (OOS) results for residual solvent (b)(4) in API batches. The firm retested and released batches without scientific justification for disregarding initial OOS results, and lacked a plan for future OOS investigations or proper documentation. 2. **Equipment Maintenance and Cleaning (21 CFR 211.67(a)):** Dedicated equipment showed visible rust, dents, and scratches on product contact surfaces. The firm's response lacked a plan for routine equipment maintenance, repairs, and replacement. 3. **Computer System Controls (21 CFR 211.68(b)):** Laboratory equipment, specifically HPLC instruments, lacked appropriate controls. Audit trails showed a pattern of aborted runs and single run entries without documented investigations. Employees used an administrative login to abort runs, preventing individual attribution, indicating data integrity issues.

The FDA noted the firm is using a consultant for audits. The firm was previously on Import Alert 99-32 due to sourcing API from an uninspectable supplier and