FDA 483 - ALK-Abello, Inc. - October 21, 2022

AllerQuest LLC, a drug manufacturer in Plainville, CT, was inspected by the FDA and received 11 observations. The inspection revealed significant deficiencies across aseptic processing, environmental monitoring, equipment design, component testing, laboratory controls, and quality system investigations. These issues indicate a high risk of contamination and product quality concerns for their sterile drug product, PRE-PEN Injection.