# FDA 483 - Pharmaceutics International Inc - November 09, 2018

Source: https://www.globalkeysolutions.net/records/483/pharmaceutics-international-inc/9e005824-a2d7-45ef-897c-1a863e8ef353

> FDA 483 for Pharmaceutics International Inc on November 09, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutics International Inc
- Inspection Date: 2018-11-09
- 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, from October 23 to November 9, 2018, revealed significant deficiencies in the manufacturing of non-sterile human and animal drugs. The firm exhibited systemic failures across quality control, laboratory operations, investigation processes, material storage, and facility maintenance. These issues indicate a lack of adherence to established procedures and regulatory requirements, potentially impacting drug product quality and integrity.

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## Related Officers

- [James M. Swann](https://www.globalkeysolutions.net/people/james-m-swann/6100d7a8-14e7-493b-9e2b-500a92e3c870)
- [Investigator](https://www.globalkeysolutions.net/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)
- [Staff Director](https://www.globalkeysolutions.net/people/alison-n-stieg/d6a4db05-dfa1-4b71-a08f-088aff746099)
- [David A Olivo](https://www.globalkeysolutions.net/people/david-a-olivo/f6509171-dd74-4c8d-9bcd-4e81d4789c40)
- [National Expert, Pharmaceutical](https://www.globalkeysolutions.net/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)

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