# FDA 483 - Pharmaceutics International Inc - July 10, 2020

Source: https://www.globalkeysolutions.net/records/483/pharmaceutics-international-inc/643a5cd2-3c8d-4a2b-9a43-e72810bbabac

> FDA 483 for Pharmaceutics International Inc on July 10, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutics International Inc
- Inspection Date: 2020-07-10
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Pharmaceutics International Inc. in Hunt Valley, MD, identified deficiencies in their vendor qualification program. The firm accepted component supplier analyses without adequately validating the reliability of those analyses, failing to perform full testing on critical drug product components. This indicates a significant concern regarding the quality control of incoming materials.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)
- [Robert J. Martin](https://www.globalkeysolutions.net/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

Company: https://www.globalkeysolutions.net/companies/pharmaceutics-international-inc/89d3a795-b80a-4c2b-81fe-20abd08cf281

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e