FDA 483 - Meridian Medical Technologies, Inc. - October 09, 2013

From September 25 to October 9, 2013, the FDA inspected Meridian Medical Technologies, a Pfizer Company, a sterile drug manufacturer located at 1945 Craig Road, Saint Louis, MO, and 1444 Strassner Rd., St. Louis, MO. The inspection revealed several cGMP deviations and contract non-conformances, many of which were repeat observations from previous inspections.

Key violations include: 1. **Failure to Validate Remediation Process:** The process for remediating ATNAA auto-injectors was not validated. Process Validation 13-134 was executed without an approved protocol, and prior to verification of SOPs, instrument calibration, process parameters, and training. This validation used the same protocol as a previously failed validation (13-133) without investigating the root cause or implementing corrective actions. The firm also failed to revalidate the process after significant changes to the remediation program, including changes to check weighing scales and flow processes. This is a repeat observation.

2. **Insufficient Qualification:** The firm proceeded to process validation for ATNAA auto-injectors without successful Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Specifically, an IQ/OQ for a critical scale was performed while the scale was out of service, and another critical scale was not assessed. A PQ protocol had an unexplained accountability discrepancy that was not investigated before approval.