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

Source: https://www.keypedia.com/records/483/ultratab-laboratories-inc/cf7b216f-b40d-4980-a8c7-046281a975e5

> FDA 483 for ULTRAtab Laboratories, Inc. on January 31, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ULTRAtab Laboratories, Inc.
- Inspection Date: 2020-01-31
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

## Related Documents

- [483 - 2019-02-01](https://www.keypedia.com/records/483/ultratab-laboratories-inc/44a605d4-aa61-4044-a075-a2ce67bd620c)
- [483 - 2021-09-14](https://www.keypedia.com/records/483/ultratab-laboratories-inc/f67de1b8-dce3-47f9-b972-260e1dc1aaab)

## Related Officers

- [Consumer Safety Officer Drug Specialist](https://www.keypedia.com/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)

Company: https://www.keypedia.com/companies/ultratab-laboratories-inc/5455d350-8084-4833-9610-a069ea634da7

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961