FDA 483 - Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center - March 08, 2017

The FDA issued a Form 483 to Puget Sound Drug Corporation, operating as Key Compounding Pharmacy, following an inspection from January 26 to March 8, 2017. The inspection identified significant deficiencies in the company's manufacturing practices for both sterile and non-sterile drug products, indicating potential violations of Good Manufacturing Practice (GMP) regulations. Key issues included widespread actionable microbial contamination in critical aseptic areas, with insufficient risk assessment for affected products. Inspectors noted severe shortcomings in aseptic cleaning and disinfection procedures, such as leaving dirty equipment in sterile hoods, using expired disinfectants, and lacking proper documentation for cleaning solutions and contact times. Environmental monitoring was found to be inadequate, and the firm failed to thoroughly investigate sterility test discrepancies, particularly when an external lab failed a batch that passed in-house. Further observations highlighted personnel non-compliance, including inadequate glove disinfection, and the use of non-sterile materials like paper/cardboard and unsuitable wooden tools in controlled environments. The company lacked assurance of sterility for container/closure systems, exhibited inadequate pressure differentials in controlled rooms, and failed to certify ISO-5 areas under dynamic conditions. Critically, practices for handling highly potent drugs were deficient, posing a risk of cross-contamination due to poor cleaning, airborne dust, and inappropriate gowning practices. Key Compounding Pharmacy is required to promptly address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards and safeguard product quality and patient safety.