FDA 483 - Brigham and Women's Hospital - August 22, 2019

An FDA inspection of Brigham and Women's Hospital, a PET Manufacturer in Boston, MA, revealed critical deficiencies in their manufacturing processes. The firm failed to maintain adequate facilities to prevent contamination, establish and follow written quality assurance procedures, and conduct proper investigations into deviations. Additionally, issues were identified with the qualification of analytical methods and the lack of a documented change management procedure, indicating significant concerns regarding the quality and purity of their sterile PET drug products.