FDA 483 - The General Hospital Corporation - June 13, 2022

The General Hospital Corporation, a PET drug manufacturer in Boston, MA, received a Form 483 with significant observations related to quality control and aseptic processing. The inspection revealed failures in investigating microbial contamination and environmental excursions, inadequate production controls, deficiencies in cleaning procedures and equipment qualification, and a lack of adherence to aseptic techniques and quality assurance protocols. These issues indicate a moderate level of severity, with several repeat observations from a previous inspection.