FDA 483 - JHP Pharmaceuticals, LLC - December 28, 2012

This FDA Form 483 details observations from an inspection, citing failures in quality control and aseptic processing for drug products purported to be sterile.

**Violations and Observations:**

1. **Inadequate Discrepancy Review:** The facility failed to thoroughly review unexplained discrepancies, specifically regarding glass particles found in or on vials. Investigations into events PR 4940, PR 4649, and PR 4380 (related to broken glass vials in Thrombin lots 594617F and 594667F) lacked sufficient scientific evidence for impact assessment and a thorough review of records. Event PR 4940 had no root cause investigation. These lots were distributed despite these issues, and a recall for a manufactured lot was initiated due to glass particle complaints.

2. **Deficient Microbiological Contamination Prevention Procedures:** * **Aseptic Process Simulation (APS) Master Plan Deficiencies:** * No documented scientific rationale supports the sufficiency of personnel participation requirements in media fills to represent routine commercial filling operations, especially regarding the duration personnel remain in the filling area and perform multiple interventions. * No written specification for the number of vials/bottles or length of time is required to challenge the slowest and fastest line speeds. Media fill batches (e.g., #50394A, #50380I) did not adequately challenge