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

Source: https://www.globalkeysolutions.net/records/483/pharmaceutics-international-inc/937931f6-45c4-44ee-8b03-39ff1917c695

> 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: Pharmaceutics International Inc. in Cockeysville, MD, a drug product manufacturer, was cited with ten observations during an FDA inspection. The inspection revealed significant deficiencies across multiple areas, including inadequate investigations into out-of-specification results, failures in maintaining aseptic processing environments, insufficient cleaning and maintenance procedures, and a lack of proper validation for analytical methods and manufacturing processes. These issues indicate a systemic breakdown in quality control and adherence to cGMP requirements for sterile drug product manufacturing.

## Related Documents

- [483 - 2016-04-04](https://www.globalkeysolutions.net/records/483/pharmaceutics-international-inc/6fb09bb0-c571-4f95-9373-92e75ada3ab8)
- [483 - 2017-10-27](https://www.globalkeysolutions.net/records/483/pharmaceutics-international-inc/1072b5e6-ef5e-404d-a0b3-54063b982137)
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- [483 - 2021-09-29](https://www.globalkeysolutions.net/records/483/pharmaceutics-international-inc/98c0fefd-6d0c-4a86-ac7d-593085f5d47e)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [investigator](https://www.globalkeysolutions.net/people/rachael-oyewole/bc642edb-4124-4cd1-b979-0d752ead1bfd)
- [Vivin George](https://www.globalkeysolutions.net/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)
- [Regional Manager](https://www.globalkeysolutions.net/people/jonah-s-ufferfilge/6bcd2028-9aca-4704-bd7b-c835874fad9d)
- [Investigator](https://www.globalkeysolutions.net/people/kristina-l-conroy/d6f2d9e4-f547-4bb2-9531-157b5890fae0)

Company: https://www.globalkeysolutions.net/companies/pharmaceutics-international-inc/38fdf7bd-a7f3-486e-b74d-13b87414922e

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