# FDA 483 - Pharmaceutics International, Inc. - July 10, 2020

Source: https://www.keypedia.com/records/483/pharmaceutics-international-inc/1f4d0f6f-9d88-4271-9537-82cbb1c04111

> FDA 483 for Pharmaceutics International, Inc. on July 10, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutics International, Inc.
- Inspection Date: 2020-07-10
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Pharmaceutics International, Inc. in Cockeysville, MD, a pharmaceutical manufacturer, received five observations during an FDA inspection from July 6-10, 2020. The inspection revealed significant deficiencies in aseptic processing, including inadequate equipment design and maintenance, insufficient environmental controls, and a lack of established procedures to prevent microbiological contamination. These issues collectively compromise the sterility assurance of drug products manufactured at the facility.

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- [EIR - 2022-11-14](https://www.keypedia.com/records/eir/pharmaceutics-international-inc/ef206f73-a4e1-444d-aae9-d09577c023c9)

## Related Officers

- [Robert J. Martin](https://www.keypedia.com/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)
- [Investigator](https://www.keypedia.com/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e