FDA 483 - Medique Products - July 18, 2024

During an inspection conducted from July 16 to 18, 2024, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to UniFirst First Aid + Safety, a drug repackager located in Fort Myers, FL. The inspection revealed a significant observation related to the firm's quality system, indicating that the responsibilities and procedures applicable to the quality control unit were not fully adhered to. Specifically, the FDA noted two key deficiencies. First, the company's quality unit failed to perform adequate inspections of incoming finished Over-the-Counter (OTC) drug products and their packaging prior to acceptance into the facility, which deviated from their established written procedures. Additionally, the firm did not consistently receive Certificates of Analysis for these incoming drug products, as exemplified by a shipment of Menthol Cough Drops packaged without a COA. Second, UniFirst First Aid + Safety did not retain samples of incoming finished OTC drug products after packaging and storage, contrary to their own retention sample system procedure. Examples included Sterile Eyewash bottles and Lidocaine Burn Gel. These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, highlight deviations from current Good Manufacturing Practices (GMP). While the FDA 483 is an inspectional observation report and not a final determination of compliance, UniFirst First Aid + Safety is expected to respond by discussing any objections or by implementing and submitting comprehensive corrective actions to address the identified issues and ensure adherence to regulatory requirements for drug product quality and safety.