FDA 483 - Kreitchman PET Center - September 02, 2025

During an inspection conducted from August 26 to September 2, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to an unnamed firm, identifying significant objectionable conditions. The inspection revealed multiple issues primarily concerning adherence to Good Manufacturing Practices (GMP) for pharmaceutical production. Key violations included the unsuitability of laboratory analytical methods, with specific concerns regarding radiochemical purity testing procedures, incomplete documentation for blank compositions, and insufficient data supporting expiry dates for reference standards. Equipment used for testing, such as HPLC, GC, and dose calibrators, was found to be inadequate, lacking appropriate acceptance criteria or requalification after maintenance. Facility contamination control practices were deficient, including issues with personnel monitoring and storage of sterile wipes. Furthermore, the firm failed to initiate investigations for aborted production runs and environmental monitoring excursions. Stability studies were not performed annually for certain products, and changes to methods and processes were implemented without proper approval or change control. Critical electronic laboratory data lacked backup mechanisms, risking loss. Deficiencies in personnel training, including a lack of GMP refresher training and documented training for quality assurance specialists on batch record review, were also noted. Finally, master production records did not establish action limits for radiochemical yield. These observations, issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, require the firm to address each identified concern through comprehensive corrective and preventive actions and provide a formal response to the FDA.