FDA 483 - abilene nuclear llc - November 07, 2019

During an FDA inspection conducted from October 28 to November 7, 2019, Abilene Nuclear LLC, operating as National Central Pharmacy, received a Form FDA 483 with eight observations. These observations highlight significant deviations from appropriate manufacturing practices, particularly in the production of sterile drug products. Key issues included personnel engaged in aseptic processing with exposed skin, inadequate disinfection of materials before entering aseptic areas, and improper glove sanitization practices that compromised sterility. Inspectors also identified facility design flaws, such as insufficient HEPA filter coverage allowing poor quality air into controlled environments, and the use of non-sterile cleaning agents in critical ISO 5 aseptic processing zones. Additionally, the firm's media fills, intended to challenge aseptic operations, were not representative of worst-case conditions. A critical documentation deficiency was also noted: batch production records lacked a second verifier for significant steps, potentially impacting product identity, strength, quality, and purity. Abilene Nuclear LLC is required to respond to these observations by implementing comprehensive corrective actions to ensure compliance with regulatory standards for sterile drug manufacturing.