FDA EIR - Gibraltar Laboratories, Inc. - February 22, 2017

An FDA inspection of Gibraltar Laboratories, Inc., located in Fairfield, NJ, was conducted from February 13 to February 22, 2017. This inspection, initiated under the New Jersey District’s FY’17 Drug Inspections Work-plan, focused on the Quality, Laboratory Control, and Facility and Equipment Systems. The regulatory framework for the inspection included CPGM 7356.002 for Drug Manufacturing Inspections and CPGM 7371.001 for Animal Drug Manufacturing Inspections. The facility, which provides microbiology and analytical chemistry testing, and has recently incorporated terminal sterilization, did not receive any formal FDA-483 Inspectional Observations. However, the inspection concluded with significant discussions with management regarding several areas needing improvement. Main issues identified included inadequate thorough review of testing documentation, which resulted in instances of microbiology technicians using incorrect test methods or failing to follow proper protocols. Additionally, a dry heat sterilizer (GBL #433344) in the sterilization room was pending Performance Qualification (PQ) before use, and a pH Meter lacked a data printer to supplement manual data recordings. In response, management committed to revising standard operating procedures (SOPs) to enhance quality checks for test method assignment and sample verification, integrating a data printer with the pH Meter, and completing the Performance Qualification for the dry heat sterilizer.