FDA 483 - The General Hospital Corporation - June 17, 2019

The General Hospital Corporation received a Form 483 citing significant deficiencies in quality assurance, facility control, and operational procedures for sterile PET radiopharmaceutical drug products. Observations included inadequate investigations into sterility failures, untimely field alert reporting for contaminated products, and facility issues like repeated cleanroom leaks and poor environmental monitoring. These issues indicate a high risk to product sterility and patient safety.