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

Source: https://www.globalkeysolutions.net/records/483/ultratab-laboratories-inc/3619c0de-b04b-4546-a5fe-77160388301c

> 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: New Jersey District Office
- Summary: An FDA inspection of ULTRAtab Laboratories, Inc. in Highland, NY, a control testing laboratory, revealed significant deficiencies across multiple areas of its operations. The firm failed to adequately investigate out-of-specification results, maintain proper stability testing programs, ensure data integrity in chromatographic systems, and validate test methods. Additionally, the inspection found issues with laboratory controls and a lack of adequate employee training, indicating systemic problems with their quality control and manufacturing practices.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Investigator](https://www.globalkeysolutions.net/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)
- [Consumer Safety Officer Drug Specialist](https://www.globalkeysolutions.net/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)

Company: https://www.globalkeysolutions.net/companies/ultratab-laboratories-inc/4f5a7231-984f-49b6-92cb-a82ef790e146

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248