Brookfield Medical/Surgical Supplies, Inc. – FDA 483, Dec 21, 2018

During an FDA inspection conducted from December 10 to December 21, 2018, Brookfield Medical/Surgical Supply, Inc., a 503B Outsourcing Facility, received eight observations on a Form FDA 483, indicating significant deviations from regulatory requirements. The primary issues centered on a lack of adequate controls for manufacturing sterile drug products. Key violations included the absence of written procedures for production and process controls, specifically failing to validate manufacturing processes for sterile injectables like Triamcinolone Acetonide and Methylprednisolone Acetate Suspensions, despite having produced numerous lots. The facility also exhibited deficiencies in environmental monitoring within aseptic processing areas, where conditions were not continuously monitored, and a critical disinfectant efficacy study was not performed for cleaning agents used on manufacturing surfaces. Furthermore, Brookfield Medical/Surgical Supply, Inc. failed to adequately test incoming active pharmaceutical ingredients for microbiological contamination (bioburden and endotoxins) before use in sterile products. Aseptic processing procedures were not consistently followed by operators, and equipment maintenance and calibration practices were found to be insufficient, potentially compromising product quality. A significant finding was the complete absence of retain samples for any finished drug products manufactured since 2015. Lastly, the company was observed to be compounding drug products, such as Methylprednisolone Acetate and Triamcinolone Acetonide Suspensions, that are essentially copies of FDA-approved drugs, which is prohibited for 503B facilities unless specific criteria are met. The firm is required to address these serious observations to ensure the safety, identity, strength, quality, and purity of its drug products.