FDA 483 - Sheffield Pharmaceuticals, LLC - June 18, 2025

Sheffield Pharmaceuticals, LLC, a drug and medical device manufacturer in New London, CT, received a Form FDA 483 citing significant quality system deficiencies. Observations included failures to thoroughly investigate deviations for finished drug products, inadequate facility maintenance with active roof leaks, and overdue annual product reviews. Additionally, the firm was cited for issues with medical device design controls and incomplete device history records regarding Unique Device Identification.