FDA 483 - Kettering Medical Center - May 09, 2025

An FDA inspection of Kettering Medical Center, a PET drug manufacturer in Kettering, OH, revealed significant deficiencies in quality assurance and production oversight. The firm failed to ensure adequate personnel for QA functions, maintain unique and accurate batch production records, and conduct thorough investigations into failed or aborted batches. These issues indicate a lack of control over PET drug manufacturing processes, potentially impacting product safety, identity, strength, quality, and purity.