# FDA 483 - Pharmaceutics International Inc - March 24, 2017

Source: https://www.globalkeysolutions.net/records/483/pharmaceutics-international-inc/b07bb327-5fc1-42c1-84cd-82046c777127

> FDA 483 for Pharmaceutics International Inc on March 24, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutics International Inc
- Inspection Date: 2017-03-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Pharmaceutics International Inc. in Hunt Valley, MD, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate investigations into product failures and discrepancies, a backlog of unaddressed customer complaints and quality events, and a failure to complete annual product reviews. Additionally, the firm lacked appropriate controls over electronic records for change controls and work orders, indicating a systemic issue with data integrity and quality oversight.

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## Related Officers

- [Senior Program Coordinator](https://www.globalkeysolutions.net/people/chaltu-nwakijra/fb7fd592-2118-4547-af1e-92f61dc5ad94)
- [Tonia F. Bernard](https://www.globalkeysolutions.net/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)
- [Director, Enterprise Regulatory Compliance](https://www.globalkeysolutions.net/people/nicholas-a-violand/c0c3ee7a-8adb-43d2-974c-06220ef8e8eb)

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