ULTRAtab Laboratories, Inc.January 31, 2020

FDA 483 - ULTRAtab Laboratories, Inc. - January 31, 2020

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Record Details

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.

Company: ULTRAtab Laboratories, Inc.
Inspection Date: January 31, 2020
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East I
Person: Sony Mathews (Consumer Safety Officer Drug Specialist)

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ID · cf7b216f-b40d-4980-a8c7-046281a975e5