FDA 483 - Professional Partners, Inc./ Westcliff Compounding Pharmacy - May 09, 2016

An FDA inspection conducted from April 20 to May 9, 2016, at Professional Partners, Inc. / Westcliff Compounding Pharmacy in Newport Beach, California, identified significant deficiencies in their manufacturing processes for sterile drugs, particularly Testosterone hormone pellets. The observations, detailed in a Form FDA 483, indicate a lack of adherence to Current Good Manufacturing Practices (CGMP).

Key violations include inadequate controls for sterile drug production. The facility lacked validated procedures for sterilizing drug product containers and closures, and did not test them to ensure they were pyrogen-free. Sterilization processes for Testosterone hormone products were not adequately validated, and approximately 61 batches of these sterile pellets were distributed without endotoxin testing.

Environmental monitoring in aseptic processing areas was found deficient, with procedures not requiring sampling during production and a failure to perform routine monitoring. Equipment cleaning and maintenance procedures were not consistently followed, and the same cleaning apparatus was used for both potent and non-potent drug products.

Furthermore, the firm failed to investigate unexplained discrepancies, such as rejected product batches, and lacked a written stability testing program to support the assigned Beyond Use Dates for sterile drugs. Calibration of critical instruments, including balances and sterilization equipment, was also found to be inadequate or not performed.

These observations highlight fundamental issues in maintaining a state of control necessary for producing sterile drug products, necessitating comprehensive corrective actions from Professional Partners, Inc. to ensure product quality and patient safety.