Select Corporation – FDA 483, Sep 14, 2023

During an inspection conducted from September 11-14, 2023, by the U.S. Food and Drug Administration (FDA), Select Corporation, a human drug repacker located in Carrollton, TX, was cited for three significant observations. These observations highlight deficiencies in the company's quality systems, impacting compliance with good manufacturing practices for drug products.The primary issues included a lack of adequate written procedures for the receipt, storage, handling, and approval of incoming components. Specifically, the company's "Incoming Shipment PROCEDURE" did not detail the examination of shipping containers for damage, nor did it require quarantining compromised products. Inspectors observed multiple instances of damaged product boxes in inventory without documented integrity checks.Secondly, Select Corporation's annual quality standards review procedures were found to be deficient. The "Annual Product Review PROCEDURE" failed to include a review of deviations, investigations, and corrective or preventive actions, which are crucial for assessing product quality over time.Finally, the FDA noted a failure to maintain written records for investigations into unexplained discrepancies. Deviations and their subsequent investigations were not consistently documented, as exemplified by cases involving incomplete labeling inspection logs and and missing lot numbers/expiration dates on product cases.To address these findings, Select Corporation must revise and implement comprehensive procedures for material control, enhance its annual product review process to include critical quality data, and establish a robust system for documenting all deviations and their investigations. These actions are essential to ensure the safety, quality, and regulatory compliance of its repackaged drug products under the Federal Food, Drug, and Cosmetic Act.