FDA 483 - Reliant Compounded Solutions Monroe, LLC - July 27, 2021

Compounded Solutions in Pharmacy, LLC in Monroe, CT was inspected and cited for multiple deficiencies related to aseptic processing, environmental controls, and product integrity. Observations included improper disinfection of materials, inadequate gowning procedures, insufficient sporicidal agent use, and compromised storage conditions for drug products. These issues indicate a significant risk to the sterility and quality of both sterile and non-sterile compounded drugs.