Generics Bidco II LLC – FDA 483, Sep 19, 2025

An FDA Form 483 was issued to an unnamed pharmaceutical firm following an inspection conducted from September 15-19, 2025. The inspection, led by Investigator Samantha E Cleek, revealed significant deviations from Current Good Manufacturing Practices (CGMP) within the firm's production and quality systems.A primary observation detailed the firm's failure to thoroughly investigate unexplained discrepancies. Specifically, several batches of "Tablets USP" drug products exhibited unexpected increases in tablet weights after testing. The firm's Site Quality Director attributed this to moisture, yet no formal investigation or root cause analysis was performed, and these batches were subsequently approved and released.Furthermore, the Quality Control Unit did not consistently follow established procedures. A QA technician released a manufacturing room without fully completing the "Major Changeover Form" inspection. This lapse went undetected for four days, during which two drug product batches were processed. The deviation was not properly documented or investigated according to company SOPs, nor were corrective actions recorded. Additionally, a scale was moved between manufacturing rooms and used in production without undergoing required QA verification and release, impacting multiple approved and released drug product batches. These observations indicate a systemic breakdown in adherence to quality assurance protocols and require the firm to implement comprehensive corrective and preventative actions to ensure compliance with federal regulations.