# FDA 483 - Pharmaceutics International Inc - November 14, 2022

Source: https://www.globalkeysolutions.net/records/483/pharmaceutics-international-inc/23d81323-3cfc-4b77-93b8-46e606c038b3

> FDA 483 for Pharmaceutics International Inc on November 14, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutics International Inc
- Inspection Date: 2022-11-14
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Pharmaceutics International Inc in Hunt Valley, MD, revealed significant deficiencies in their drug product manufacturing operations. Observations included inadequate cleaning processes for multi-purpose equipment, failure to properly test components from suppliers, and an insufficient stability program for drug products. These issues indicate a lack of adherence to established quality control and good manufacturing practices.

## Related Documents

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

## Related Officers

- [Vivin George](https://www.globalkeysolutions.net/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)
- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)
- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)
- [Regional Manager](https://www.globalkeysolutions.net/people/jonah-s-ufferfilge/6bcd2028-9aca-4704-bd7b-c835874fad9d)

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

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