FDA 483 - Lifetime Value Pharmacy III Inc. - February 21, 2019

An FDA inspection of Lifetime Value Pharmacy III Inc. in Santa Ana, CA, conducted from January 10 to February 21, 2019, revealed multiple significant deficiencies in their compounding pharmacy operations, documented in an FDA 483. The main violations centered on inadequate control over aseptic processing and environmental conditions, indicating a departure from good manufacturing practices. Key issues included a failure to adequately evaluate and take remedial action against microbial contamination found in ISO 5 and ISO 7 classified aseptic areas, and personnel not consistently disinfecting or changing gloves to prevent contamination. The inspection also noted visibly dirty, particle-generating equipment and surfaces in critical ISO 5 areas, as well as unsealed ceiling tiles in the ISO 7 cleanroom. Additionally, observations highlighted improper gowning practices, use of non-sterilized and unqualified equipment for sterile drug production, and general non-microbial contamination throughout production areas. The facility design itself was flagged for potentially compromising air quality by allowing poor air influx into higher classified areas. Lifetime Value Pharmacy III Inc. is required to address these observations by implementing comprehensive corrective actions to ensure compliance and patient safety.