# FDA 483 - Pharmaceutics International Inc - March 18, 2016

Source: https://www.keypedia.com/records/483/pharmaceutics-international-inc/073299e1-26d0-4892-a7f1-668a441df51b

> FDA 483 for Pharmaceutics International Inc on March 18, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutics International Inc
- Inspection Date: 2016-03-18
- 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, a drug manufacturer, revealed significant deficiencies across multiple systems. Repeated observations included inadequate environmental controls and HVAC monitoring, insufficient cleaning validation and procedures, and critical failures in data integrity and quality control unit oversight. The firm also failed to thoroughly investigate discrepancies and maintain proper production documentation, indicating systemic issues in GMP compliance.

## Related Documents

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- [483 - 2020-10-30](https://www.keypedia.com/records/483/pharmaceutics-international-inc/0646990d-3723-4aaf-8660-3f93d931b33b)

## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/zhongren-wu/416f09a6-f225-4d23-a305-34f96a5c78f0)
- [investigator](https://www.keypedia.com/people/jonathan-w-chapman/5b5134c3-71f9-4212-9429-4554d91e8aa9)

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

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