FDA 483 - Gipsco Investment Corp - June 09, 2017

During an inspection conducted from June 5 to June 9, 2017, the Food and Drug Administration (FDA) identified significant deficiencies at Gipsco Investment Corp., operating as Lee Silsby Compounding Pharmacy, a producer of sterile drug products in Cleveland Heights, Ohio. The observations, documented in an FDA Form 483, highlight several critical issues related to aseptic processing controls and environmental monitoring, which are crucial for ensuring the sterility and quality of drug products. Key violations included inadequate airflow and HEPA-filter coverage in sterile product areas, improper personnel gowning and hygiene practices such as using bare hands with sterile gowns and insufficient glove disinfection, and reusing gowns without proper sterilization. The inspection also revealed failures in environmental controls, specifically unsealed cleanroom lighting and a lack of monitoring for pressure differentials between classified areas. Furthermore, the firm's sterilization processes were found to be deficient, with inadequate cycle parameters for heat-resistant microorganisms and incorrect use of biological indicators to verify sterilization effectiveness. These observations indicate a need for immediate corrective action to align with established manufacturing practices for sterile products. The company is required to thoroughly investigate these deficiencies and implement robust corrective and preventive actions to ensure the safety, quality, and purity of their compounded sterile drug products.