# FDA 483 - Pharmaceutics International Inc - November 16, 2017

Source: https://www.keypedia.com/records/483/pharmaceutics-international-inc/c0dca8aa-b540-4ad9-9302-54d60c3b66e2

> FDA 483 for Pharmaceutics International Inc on November 16, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutics International Inc
- Inspection Date: 2017-11-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Pharmaceutics International Inc in Hunt Valley, MD, received a Form 483 citing significant deficiencies in laboratory controls, record-keeping, and equipment management. Issues included inadequate assay testing procedures, improper handling of out-of-specification results, deficient calibration procedures, and failures in OOS and CAPA investigations. Additionally, problems with sample handling, equipment qualification, and environmental controls were noted, indicating a broad lack of adherence to cGMP.

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

## Related Officers

- [Consumer Safety Officer at FDA U.S. Food and Drug Administration](https://www.keypedia.com/people/ko-u-min/9bb5f33e-857b-4c6f-a550-fdb439760e30)
- [James M. Mason](https://www.keypedia.com/people/james-m-mason/a9f601a9-5d81-4386-90dc-80466edb5880)
- [Supervisory Consumer Safety Officer, China Office](https://www.keypedia.com/people/marcus-a-ray/d394d757-5569-4697-bec1-c24113e29d6f)

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