FDA EIR - Fagron Compounding Services - March 24, 2022

An FDA inspection of Fagron Compounding Services (also known as Fagron Sterile Services), a registered 503B Outsourcing Facility in Wichita, KS, was conducted from March 1 to March 24, 2022. The inspection focused on the company's production of human sterile drug products under the regulatory framework for outsourcing facilities. Six significant issues were identified, leading to the issuance of an FDA Form 483. Key violations included deficiencies in the cleaning and disinfection systems for aseptic processing areas, a lack of qualification and proper recording for equipment used in batch records, and the absence of written procedures for in-process controls and examinations. Additionally, the facility failed to ensure drug product testing and release conformed to final specifications prior to distribution, and the quality control unit did not adequately review and approve laboratory control mechanisms. Most notably, the company was observed compounding drug products using bulk drug substances that do not comply with Section 503B of the Act, meaning they were not on the drug shortage list or an FDA-developed list for clinical need. Management was reminded of their responsibility to adhere to drug Current Good Manufacturing Practices (cGMPs) and the potential consequences of non-compliance. Fagron Compounding Services is required to submit a formal response to the FDA within 15 business days addressing these observations.