# FDA 483 - Pharmaceutics International Inc - September 29, 2021

Source: https://www.keypedia.com/records/483/pharmaceutics-international-inc/eefcf4af-d937-4223-a88d-495e224ed1ec

> FDA 483 for Pharmaceutics International Inc on September 29, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutics International Inc
- Inspection Date: 2021-09-29
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Pharmaceutics International Inc., a non-sterile drug manufacturer in Hunt Valley, MD, was cited for significant deficiencies across its quality, facilities, equipment, production, and material systems. The inspection revealed repeated failures in thorough investigations of discrepancies, inadequate quality control unit procedures, and insufficient controls over electronic equipment and data. These issues indicate a systemic lack of adherence to cGMP regulations, posing risks to drug product quality and integrity.

## Related Documents

- [EIR - 2022-11-14](https://www.keypedia.com/records/eir/pharmaceutics-international-inc/2adaea6c-1bf7-4220-a187-496f2233d83b)
- [483 - 2018-11-09](https://www.keypedia.com/records/483/pharmaceutics-international-inc/9e005824-a2d7-45ef-897c-1a863e8ef353)
- [483 - 2024-12-06](https://www.keypedia.com/records/483/pharmaceutics-international-inc/e2e84415-5d23-4319-901b-b9bbb7761500)
- [483 - 2016-03-18](https://www.keypedia.com/records/483/pharmaceutics-international-inc/073299e1-26d0-4892-a7f1-668a441df51b)
- [483 - 2017-11-16](https://www.keypedia.com/records/483/pharmaceutics-international-inc/c0dca8aa-b540-4ad9-9302-54d60c3b66e2)

## Related Officers

- [FDA Biologics Investigator](https://www.keypedia.com/people/viviana-matta/6fecf0ca-0edc-4538-a57e-72642f41b5c7)
- [Investigator](https://www.keypedia.com/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)
- [investigator](https://www.keypedia.com/people/shirshendu-k-deb/d8e51b5d-e39c-46c5-893d-b01261babec4)
- [Kathleen M. Jordan](https://www.keypedia.com/people/kathleen-m-jordan/e08b786a-47bf-4e78-ae96-9d94cdc20bdb)

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

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64