ULTRAtab Laboratories, Inc. – FDA 483, Jan 31, 2020

ULTRATAB Laboratories, Inc. in Highland, NY, a pharmaceutical drug manufacturer, received a Form 483 with seven observations during an inspection from January 21-31, 2020. The observations highlight severe deficiencies in the quality control unit's authority and procedures, equipment cleaning and maintenance, data integrity for computer systems and excel templates, and validation of test methods. Two observations regarding data integrity and test method validation were repeats from a previous 2018 inspection, indicating persistent non-compliance.