Brookfield Medical/Surgical Supplies, Inc. – FDA 483, May 10, 2024

An FDA inspection of Brookfield Medical/Surgical Supplies, Inc., a 503B Outsourcing Facility, conducted from April 22 to May 10, 2024, revealed significant compliance issues. The facility was cited for multiple violations under the Federal Food, Drug, and Cosmetic Act, highlighting critical breakdowns in their quality systems.

Key observations included a failure to follow established procedures designed to prevent microbiological contamination of sterile drug products, a recurring issue from a previous inspection in 2022. Specific instances involved operators compromising sterile environments during cleaning and inadequate dynamic airflow studies. Additionally, the firm did not consistently adhere to its written cleaning and maintenance procedures for equipment and controlled areas, with investigators noting missed cleaning steps and improper material handling in ISO 7 and ISO 8 rooms. There was also a lapse in performing required re-cleaning after a detected microbiological contamination event in an ISO 5 area.

Further deficiencies included the absence of adequate written procedures for investigating out-of-specification results from environmental and personnel monitoring, which is crucial for assessing potential impacts on drug product quality. Lastly, multiple drug product container labels were found to be non-compliant with Section 503B(a)(10)(B) of the FD&C Act, as they lacked essential information for adverse event reporting and comprehensive directions for use, including dosage and administration. Brookfield Medical/Surgical Supplies, Inc. must address these observations by implementing robust corrective and preventive actions, revising procedures, and ensuring adherence to regulatory standards to ensure drug product quality and patient safety.