FDA 483 - Medical Center Pharmacy, Inc. - October 13, 2015

An FDA inspection conducted at Medical Center Pharmacy, Inc. from September 28 to October 13, 2015, revealed multiple critical deficiencies in their production of sterile drug products. The observations highlight significant non-compliance with established manufacturing quality standards. Major issues included inadequate validation of sterilization and depyrogenation processes, encompassing media fills that did not simulate entire production, and unvalidated sterilization methods for finished products and glassware. Personnel practices were deemed inappropriate, with non-sterile and inadequately covering garments, and the reuse of protective clothing in aseptic areas. Environmental control failures were noted, such as non-sterile cleaning solutions, infrequent monitoring of aseptic environments, and improper air pressure differentials. Furthermore, the facility exhibited equipment not suitable for its intended use, lacking proper design for cleaning and maintenance, and a critical instrument remained uncalibrated. The company released drug products, including Morphine/Clonidine Injectable, that failed to meet established specifications. Other violations involved insufficient laboratory testing for sterile products, the absence of a written stability testing program, and the compounding of penicillin and cytotoxic drugs in shared production areas. The company is required to formally address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with federal regulations governing sterile drug manufacturing.