FDA 483 - Empower Pharmacy - November 25, 2015

An FDA inspection of Empower Clinic Services, LLC in Houston, TX, a producer of sterile drug products, revealed significant deficiencies in their manufacturing processes. The firm failed to thoroughly investigate non-sterile batches, lacked adequate validation for sterilization processes, and exhibited shortcomings in environmental monitoring. Additionally, issues were noted with equipment maintenance, cleaning procedures, and the absence of a written stability testing program for drug products.