FDA 483 - Reliant Compounded Solutions Monroe, LLC - August 23, 2023

During an FDA inspection from August 1-23, 2023, at Reliant Compounded Solutions Monroe, LLC, a producer of non-sterile and sterile drug products located at 810 Main St, Monroe, CT, several observations were made. Michael H. Roberge, Pharmacy In-Charge, was issued the report.

Observation 1 noted personnel making rapid movements in or immediately adjacent to a critical area (ISO 5 Biological Safety Cabinet - BSC) while aseptically processing Triple P Injectable. This included "tossing" materials into the BSC and rapid movements within it, likely disrupting unidirectional airflow.

Observation 2 stated that smoke studies performed in June and December 2022 for the Hazardous BSC, Non-Hazardous BSC, and another unit were inadequate. The videos presented were brief and did not sufficiently demonstrate dynamic sterile compounding operations.

Observation 3 indicated that sterile drugs were exposed to air quality lower than ISO 5. Specifically, stock solutions, such as Dexamethasone 12mg/mL Preservative Free (PF) stock solution (lot 06072023), were stored in an unclassified Storage Room refrigerator after their container closure systems had been punctured multiple times for compounding Dexamethasone OPHTH (PF) 0.01% and 0.1% Solutions. This compromised the sterility of the stock solutions throughout their assigned expiry period.