FDA 483 - ULTRAtab Laboratories, Inc - September 14, 2021

An FDA inspection of ULTRAtab Laboratories, Inc. in Highland, NY, a control testing laboratory, revealed significant deficiencies across multiple areas of its operations. The firm failed to adequately investigate out-of-specification results, maintain proper stability testing programs, ensure data integrity in chromatographic systems, and validate test methods. Additionally, the inspection found issues with laboratory controls and a lack of adequate employee training, indicating systemic problems with their quality control and manufacturing practices.