# FDA 483 - Pharmaceutics International Inc - May 22, 2015

Source: https://www.keypedia.com/records/483/pharmaceutics-international-inc/4258740a-02ff-498a-8cbb-2987d64b4ce3

> FDA 483 for Pharmaceutics International Inc on May 22, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutics International Inc
- Inspection Date: 2015-05-22
- 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, revealed significant deficiencies across its operations. The firm lacked adequate written procedures for production and process controls, failed to properly maintain equipment leading to contamination, and conducted insufficient investigations into out-of-specification results and product defects. These issues indicate a systemic failure to ensure drug product quality and prevent the recurrence of critical manufacturing problems.

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- [483 - 2017-11-16](https://www.keypedia.com/records/483/pharmaceutics-international-inc/c0dca8aa-b540-4ad9-9302-54d60c3b66e2)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/toyin-b-oladimeji/0aff4ab4-a1ff-4394-a32d-747bdc5f248b)
- [investigator](https://www.keypedia.com/people/james-m-simpson/3c0113ae-d846-4e37-aafa-13d58c465fa3)

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