FDA 483 - Sheffield Pharmaceuticals, LLC - June 18, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 7cd01947-9bfa-44de-b786-afdb286b6669