FDA 483 - Unither Manufacturing LLC. - May 22, 2019
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.
Unither Manufacturing LLC in Rochester, NY, was cited for significant quality control and equipment maintenance issues during an FDA inspection. Observations included the invalidation of out-of-specification investigations without scientific justification and deficiencies in batch production records regarding equipment identification. Additionally, the firm failed to properly maintain and sanitize equipment and utensils, leading to potential contamination risks for drug products.
ID · 2c0d7158-40a8-4436-a5ba-0d7baa943cf7