Absolute Pharmacy, LLC – FDA 483, Nov 19, 2014

During an FDA inspection conducted from October 27 to November 19, 2014, Absolute Pharmacy, LLC, an outsourcing facility located in Lutz, FL, received a Form FDA 483 detailing twelve significant observations. The inspection revealed numerous deficiencies related to the firm's sterile drug manufacturing processes, indicating a lack of compliance with established good manufacturing practices for compounded sterile products.

Key issues included a complete absence of validation for sterilization and depyrogenation processes, along with inadequate calibration documentation for critical equipment. Environmental and personnel monitoring systems were found to be deficient, lacking appropriate media, scientific rationale for sampling locations, and dynamic condition testing. Gowning procedures were inconsistent and qualifications were not performed. The facility also failed to use sterile disinfectants or sporicidal agents in classified areas.

Further concerns involved the firm's quality control, including a lack of validation for sterility and endotoxin testing, and no testing for preservative content, potency, or reconstitution times for certain sterile products prior to distribution. Batch production records were incomplete, and critical process hold times were not established. The facility also lacked a qualified vendor program and failed to verify supplier Certificates of Analysis. Finally, product labels omitted required information such as the compounding date, "Not for resale" statement, and proper adverse event reporting details, as mandated for outsourcing facilities under relevant sections of the regulatory framework. The firm is required to submit a comprehensive response detailing its corrective and preventive actions to address these serious deviations.