FDA EIR - Gibraltar Laboratories, Inc. - February 03, 2015

An FDA inspection of Gibraltar Laboratories, Inc., a control-testing laboratory located in Fairfield, NJ, was conducted from January 28 to February 3, 2015. The inspection's scope included Good Manufacturing Practices (GMP) and pre-approval coverage for new animal drug applications (NADA), abbreviated new drug applications (ANDA), as well as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P). Regulatory frameworks followed included Compliance Programs 7356.002, 7368.001, 7346.832, and 7341.002. The inspection comprehensively reviewed the firm's Quality and Laboratory Control Systems, covering aspects like SOPs, investigations, training, equipment calibration, environmental monitoring, and testing records. Significantly, no deficiencies were noted, and no FDA-483 (Inspectional Observations) was issued during this inspection. This positive outcome led to recommendations for approval for the NADA and ANDA applications covered. The only specific discussion with management involved a recommendation to update the firm's SOP 153M, "Environmental Monitoring," to explicitly state that monitoring is conducted under static conditions (without personnel simulating a working environment). Gibraltar Laboratories committed to implementing this change. The inspection concluded without any refusals or samples collected by the FDA, affirming the laboratory's compliance with regulatory standards.