Select Corporation – FDA 483, Sep 14, 2023

Select Corporation, a human drug repacker in Carrollton, TX, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm lacked adequate written procedures for the receipt and inspection of incoming drug product shipments, leading to damaged products not being properly examined or quarantined. Additionally, the company's annual product review procedures were found to be deficient, failing to include reviews of deviations and investigations, and there was a systemic failure to record investigations into unexplained discrepancies.