FDA 483 - Chen Shwezin, Inc. dba Park Compounding Pharmacy - September 11, 2015

An FDA inspection conducted at Chen Shwezin, Inc. dba Park Compounding Pharmacy in Westlake Village, CA, from August 31 to September 11, 2015, identified significant deficiencies in the firm's sterile drug production processes. The inspection, documented on an FDA Form 483, highlighted a lack of adherence to regulatory expectations for drug manufacturing quality and safety.

Key violations centered on maintaining aseptic processing areas. The ISO 5 classified environment, used for sterile product preparation, was poorly maintained, exhibiting structural damage, inadequate pest control, unmonitored air pressure, and general clutter. Procedures for preventing microbiological contamination were severely lacking, including unvalidated sterilization methods, insufficient media fill studies, and observed breaches in aseptic technique by personnel. Environmental monitoring was deficient, with no consistent air or surface monitoring during production.

Furthermore, the firm used non-sterile cleaning agents and expired disinfectants. Drug products lacked expiration dates supported by stability data, and container closure systems were inadequate, posing contamination risks. Equipment, including thermometers, balances, and incubators, lacked calibration procedures. Compounding areas were not adequately segregated, with sterilization equipment located in a shared breakroom adjacent to an open bathroom.

The FDA 483 indicates the firm must address these observations by developing and implementing comprehensive corrective and preventive actions to ensure the safety, identity, strength, quality, and purity of its sterile drug products, thereby complying with federal regulations governing drug manufacturing practices.