FDA 483 - Mandell's Clinical Pharmacy - June 17, 2022

An FDA inspection of Mandell's Clinical Pharmacy in Somerset, NJ, a producer of sterile and non-sterile drug products, revealed significant deficiencies in aseptic processing. Observations included inadequate media fills that did not simulate worst-case conditions, improper gowning practices, and a lack of assurance regarding ISO 5 air quality during sterile drug production. These issues indicate potential risks to the sterility and quality of drug products.