FDA 483 - JHP Pharmaceuticals, LLC - March 29, 2012

This FDA Form 483 details multiple observations from an inspection. The facility manufactures various injectable drug products, including Pitocin, Coly-Mycin M, Thrombin, Dantrium, Ketalar, Brevital, and Tigan.

Key violations include: 1. **Inadequate Investigation Records:** Investigations into unexplained discrepancies, such as incorrect storage conditions on Pitocin labels (Pitocin 10 mL lots 225867 and 231423), did not fully address sterility assurance for distributed vials. An open investigation for Coly-Mycin M (lot 2204) regarding a failed stopper washer cycle requalification (affecting 6 lots) lacked assessment of marketed lots. 2. **Insufficient Corrective Actions:** Corrective actions for environmental monitoring deviations (PR 1479, 1539) were not extended to all applicable departments, leading to a repeat deviation (PR 1995) for failure to initiate NVP monitoring. 3. **Undefined Quality Unit Responsibilities:** The duties and responsibilities of the Quality Unit were not clearly defined in written procedures, exemplified by a Pitocin label error (lots 231423, 225867) reported via Field Alert. 4. **Failure to Follow Procedures:** Deviation/Investigation Management procedures (SOP-QLA-MQA-03437