# FDA 483 - PediFix, Inc. - February 12, 2024

Source: https://www.globalkeysolutions.net/records/483/pedifix-inc/a6245594-0fa9-40cf-8f6c-015b5d9cab84

> FDA 483 for PediFix, Inc. on February 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PediFix, Inc.
- Inspection Date: 2024-02-12
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Pedifix, Inc. in Brewster, NY, a repackager/relabeler, was cited for three significant issues during an FDA inspection. The firm failed to ensure proper quality control over contract manufactured drug products, lacked validated computer controls for inventory management, and did not visually examine reserve samples for deterioration. These observations indicate deficiencies in quality unit responsibilities, data integrity, and sample retention procedures.

## Related Officers

- [Drug Investigator](https://www.globalkeysolutions.net/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)

Company: https://www.globalkeysolutions.net/companies/pedifix-inc/7a6cb7c8-fc8a-42c1-8b8a-7ea5fdd7a346

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