FDA 483 - Merck Sharp & Dohme LLC

Merck Sharp & Dohme Corporation in West Point, PA, was inspected regarding its biologics and vaccine operations. The inspection revealed significant issues including inadequate environmental controls in a vaccine production area, poor facility maintenance with a leaking roof affecting GMP spaces, and failures in complaint handling and medical device reporting for broken prefilled vaccine syringes. These observations indicate potential risks to product quality and patient safety.