FDA 483 - Edge Pharma, LLC - January 20, 2017

An FDA inspection conducted between January 3 and January 20, 2017, at Edge Pharmacy Services, LLC, an Outsourcing Facility located in Colchester, VT, revealed significant deviations from Current Good Manufacturing Practices. The firm received a Form FDA 483 detailing four main observations. Firstly, the facility demonstrated inadequate control over air pressure and microorganisms during drug product manufacturing. Airflow studies did not accurately represent production conditions, and there was insufficient control of cleanroom doors, potentially compromising designed pressure cascades. Equipment placement also varied, impacting validated airflow patterns. Secondly, the firm lacked separate or defined areas to prevent contamination. Notably, cleanrooms and equipment used for potent or cytotoxic drugs like Mitomycin for ocular injection were also utilized for non-hazardous allergen test injections. Crucially, cleaning procedures for changing between these product types were not validated to prevent cross-contamination. Thirdly, the Quality Control Unit failed to review and approve drug product production and control records for compliance with established procedures before batch release. A specific instance involved the release of Triamcinolone Ophthalmic Injection without documented approval for deviations from sterilization processes. Finally, the firm's laboratory testing procedures for pyrogens were deficient. This included a failure to qualify new lots of endotoxin testing reagents before use and incomplete validation of endotoxin testing methods, as instructed by the vendor. Edge Pharmacy Services, LLC is required to address these observations with appropriate corrective actions to ensure compliance with regulatory standards for drug manufacturing.