FDA EIR - Gibraltar Laboratories, Inc. - November 20, 2019

An FDA inspection of Gibraltar Laboratories, Inc., a contract testing laboratory in Fairfield, NJ, was conducted from November 12-20, 2019. This cGMP and pre-approval inspection covered the firm’s analytical and microbiology testing services for drug products. The inspection identified three significant observations, leading to the issuance of a Form FDA 483. Firstly, the company failed to consistently follow established laboratory control mechanisms, as evidenced by employees recording Good Manufacturing Practice (GMP) data in uncontrolled personal notebooks. Secondly, there was a failure to thoroughly investigate unexplained discrepancies, specifically an Out-of-Specification (OOS) result for purified water used in media preparation, where a formal investigation was not conducted. Thirdly, laboratory records were found to lack complete data derived from all necessary tests, such as missing reagent weight measurements for bacterial endotoxin testing records. These observations indicate non-compliance with the regulatory framework governing drug manufacturing and testing, including requirements for laboratory controls and complete record-keeping. Gibraltar Laboratories management acknowledged the deficiencies and committed to implementing voluntary corrective actions, including updating relevant Standard Operating Procedures and providing additional staff training. The firm stated they would submit a formal response to the agency within fifteen business days.