ChemPacific Corporation – FDA Warning Letter, Oct 9, 2010

On April 7, 2011, the FDA issued a Warning Letter to ChemPacific Corporation following a September-October 2010 inspection of their API manufacturing facility in Baltimore, Maryland. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP), rendering their APIs adulterated.

Key violations include: 1. **Incomplete Batch Records:** Failure to record quality-related activities concurrently, with back-dated and incomplete entries for Norepinephrine Bitartrate manufacturing. The firm's response was partially adequate but lacked details on actions for further inaccuracies and retrospective evaluation. 2. **Lack of Equipment Cleaning Records:** Failure to document cleaning of containers used for intermediates, specifically for Norepinephrine Bitartrate storage. The firm's commitment to reject batches was inadequate as it didn't address the practice or propose corrective actions. 3. **Inadequate OOS Investigations:** Failure to follow written procedures for out-of-specification (OOS) purity test results for Norepinephrine Hydrochloride, including initiating Phase 2 testing prematurely and analyzing insufficient samples. The updated OOS procedure was deemed inadequate for allowing invalidation of OOS results without a complete investigation. 4. **Improper Equipment Calibration:** Failure to calibrate weighing equipment (e.g., a specific scale) within its intended use range, as it was used for weights smaller than its calibration and daily verification ranges. The firm's response lacked information on a routine calibration program.