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

Source: https://www.keypedia.com/records/483/ultratab-laboratories-inc/f67de1b8-dce3-47f9-b972-260e1dc1aaab

> FDA 483 for ULTRAtab Laboratories, Inc. on September 14, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ULTRAtab Laboratories, Inc.
- Inspection Date: 2021-09-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

## Related Documents

- [483 - 2019-02-01](https://www.keypedia.com/records/483/ultratab-laboratories-inc/44a605d4-aa61-4044-a075-a2ce67bd620c)
- [483 - 2020-01-31](https://www.keypedia.com/records/483/ultratab-laboratories-inc/cf7b216f-b40d-4980-a8c7-046281a975e5)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [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