FDA 483 - Unither Manufacturing LLC. - May 22, 2019

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.