FDA 483 - Brookfield Medical/Surgical Supplies, Inc. - April 04, 2022

Brookfield Medical/Surgical Supply, Inc., a 503B Outsourcing Facility in Brookfield, CT, was inspected and cited for significant deficiencies across its manufacturing operations. Observations included poor facility maintenance, inadequate equipment cleaning validation, insufficient aseptic process validation, and a lack of defined production and process controls for sterile drug products. These issues indicate a systemic failure to ensure the quality and purity of drug products.