FDA 483 - The Feinstein Institute for Medical Research - May 09, 2025

An FDA inspection of The Feinstein Institute for Medical Research, a PET drug manufacturer in Manhasset, NY, revealed significant deficiencies in quality assurance procedures and laboratory record-keeping. The firm failed to establish written procedures for critical activities such as supplier qualification, component handling, product distribution, and quality assurance responsibilities. Additionally, the inspection found that radiochemists had administrative privileges allowing them to alter or delete data for product release testing, raising concerns about data integrity.