LeMaitre Vascular, Inc. – FDA 483, Oct 18, 2023

During a recent inspection, the FDA issued a Form 483 to an unnamed pharmaceutical manufacturing firm, detailing nine observations related to non-compliance with Current Good Manufacturing Practice (CGMP) regulations, primarily 21 CFR Part 211. Key issues highlighted include significant deficiencies in microbial control, particularly for non-sterile drug products and water systems. The firm lacked validated test methods for Burkholderia cepacia complex (BCC) recovery and routine BCC testing for USP purified water. Environmental and water system microorganisms were not identified to the species level, and a specific product, Glucagon for Injection, was not tested for BCC. Several microbial control issues were repeat observations from a previous inspection. Further concerns involved inadequate out-of-specification investigations, where failing batch results did not trigger broader reviews of other potentially impacted products or batches. Aseptic processing areas showed deficiencies, with operators compromising sterile fields during media fills. The firm also failed to adhere to established internal procedures for gowning qualification and internal audits. Computer system controls were found lacking in the Laboratory Information Management System (LIMS), where analysts could delete sample results without mandatory justification. Complaint handling procedures were deficient, failing to adequately link complaints to potential product failures or OOS investigations. Additionally, employee training for microbiology analysts was insufficient, and critical equipment like HEPA filters in incubators lacked proper calibration documentation. The firm is required to address these systemic issues with comprehensive corrective and preventive actions to ensure compliance with federal regulations and safeguard product quality and patient safety.