FDA 483 - The General Hospital Corporation - September 30, 2025

An FDA inspection of The General Hospital Corporation, a PET Drug Manufacturer in Boston, MA, revealed significant deficiencies across multiple areas of its operations. Observations included inadequate control over CGMP documents and data, unsuitable equipment and facility conditions leading to contamination risks, and failures in quality assurance and adherence to established production procedures. These issues indicate a lack of robust controls necessary to ensure the quality and purity of PET drugs.