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

An FDA inspection of ULTRAtab Laboratories, Inc., a pharmaceutical drug manufacturer in Highland, NY, revealed significant deficiencies in their quality systems. The firm failed to establish and follow adequate procedures for equipment cleaning and maintenance, including validation studies, and did not thoroughly investigate out-of-specification results or maintain proper cleaning records. These issues, including repeat observations, indicate a lack of control over manufacturing processes and product quality.