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

An FDA inspection of Lifetime Value Pharmacy III Inc., a compounding pharmacy in Santa Ana, CA, was conducted from January 10, 2019, to February 21, 2019. The inspection documented several significant observations indicating deviations from established quality and aseptic processing standards for sterile drug production. Main issues included the firm's inadequate response to microbial contamination findings in both ISO 5 aseptic processing and ISO 7 cleanroom areas, where positive environmental monitoring results did not lead to appropriate remedial actions or assessments of potentially impacted products. Additionally, personnel practices were criticized, with observations of inadequate glove disinfection during sterile compounding using non-sterile solutions, and improper gowning procedures that risked contamination. Facility and equipment deficiencies were also noted, such as visibly dirty and difficult-to-clean surfaces within the ISO 5 laminar flow hood, unsealed ceiling tiles in the ISO 7 cleanroom, and visible non-microbial contamination throughout production areas. The facility's design was observed to allow for potential influx of poor-quality air into higher classified areas due to an unmonitored air-blowing hand dryer. Furthermore, essential sterilization equipment lacked proper qualification and validation. These observations highlight the need for the company to implement comprehensive corrective actions to ensure the sterility and quality of its compounded sterile preparations.