FDA 483 - Brookfield Medical/Surgical Supplies, Inc. - July 10, 2026

Brookfield Medical/Surgical Supplies, Inc., an outsourcing facility, was inspected by the FDA from June 29 to July 10, 2026. The inspection identified critical violations of the Federal Food, Drug, and Cosmetic Act regarding quality control and sterile drug manufacturing processes. Primary issues centered on the firm"s failure to adequately investigate thirteen Out-of-Specification (OOS) potency results for several sterile products, including Betamethasone, Triamcinolone, and Morphine Sulfate. The firm frequently invalidated failing results and released products for distribution without conducting thorough root-cause analyses or independent reviews of contract laboratory data. Additionally, the Quality Control Unit demonstrated a systemic lack of oversight, failing to audit contract labs, ignoring recurring failure patterns, and prematurely closing complex investigations without implementing effective corrective actions. The inspection also revealed significant deficiencies in contamination control. The facility’s environmental monitoring program allowed for inappropriate microbial limits in sterile areas, failing to adhere to the required zero-tolerance standard for gloved fingertip samples in high-cleanliness zones. Most microbial excursions were neither identified nor investigated. To address these findings, the firm is expected to respond with a comprehensive plan for corrective and preventive actions, including enhancing quality unit oversight, auditing third-party partners, and revising environmental monitoring protocols to ensure the safety and potency of their distributed medications.