# FDA 483 - ULTRAtab Laboratories, Inc. - February 01, 2019

Source: https://www.keypedia.com/records/483/ultratab-laboratories-inc/44a605d4-aa61-4044-a075-a2ce67bd620c

> FDA 483 for ULTRAtab Laboratories, Inc. on February 01, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ULTRAtab Laboratories, Inc.
- Inspection Date: 2019-02-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Vitratab Laboratories, Inc. in Highland, NY, from January 25 to February 1, 2019, revealed a significant quality control issue. The firm's master manufacturing record for dietary supplements failed to identify necessary specifications, specifically microbial limits, to ensure product quality. This indicates a deficiency in their manufacturing process controls.

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## Related Officers

- [Marie-Elena C Puleo](https://www.keypedia.com/people/marie-elena-c-puleo/10dd4dfe-6b8d-4956-a946-3fe2e4da2ce0)

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