Unither Manufacturing LLC. – FDA 483, May 15, 2026

An FDA inspection of Unither Manufacturing LLC, a sterile and non-sterile drug manufacturer in Rochester, NY, revealed significant deficiencies across multiple quality system areas. The observations highlight inadequate controls for preventing microbiological contamination, insufficient laboratory testing, and failures in data integrity and quality control unit procedures. These issues indicate a systemic lack of adherence to cGMP requirements, posing potential risks to drug product quality and patient safety.