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

During an inspection conducted from September 25 to October 9, 2013, the FDA identified significant manufacturing and quality control deficiencies at Meridian Medical Technologies, a Pfizer Company, located in Saint Louis, MO. The inspection, which covered their sterile drug manufacturing operations, revealed multiple violations of Current Good Manufacturing Practices (cGMP) and non-compliance with contractually defined sampling standards. Key issues included a persistent failure to adequately validate the remediation process for ATNAA auto-injectors, with processes initiated without approved protocols or proper qualification of equipment. The Quality Control unit was found ineffective in preventing and investigating recurring accountability discrepancies in product lots, indicating a lack of robust corrective and preventive actions. Additionally, the company failed to follow its own written production and process control procedures, evident in incomplete batch records, non-contemporaneous documentation, and changes to critical equipment without utilizing the change control system. The inventory control system was also deemed unreliable, showing discrepancies between physical product status and system records. Furthermore, Meridian Medical Technologies did not adhere to the ISO 2859-1/ANSI/ASQ Z1.4 Standard for acceptance sampling, specifically by failing to implement switching rules for inspection levels and not collecting AQL samples randomly as required by contract and internal SOPs. Many of these observations were identified as repeat deficiencies from previous FDA inspections conducted earlier in 2013. The company is required to investigate these observations and implement comprehensive corrective actions to ensure compliance with cGMP regulations and their contractual obligations.