# FDA 483 - Pharmathen International S.A. - March 09, 2022

Source: https://www.keypedia.com/records/483/pharmathen-international-sa/2ae2f05c-8463-45f1-bfda-7495f67c5b02

> FDA 483 for Pharmathen International S.A. on March 09, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmathen International S.A.
- Inspection Date: 2022-03-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Pharmathen International S.A. in Rodopi, Greece, revealed significant deficiencies in their manufacturing operations. Observations included inadequate cleaning and disinfection procedures for aseptic processing areas, insufficient laboratory controls for inspecting drug products for particulates, and a failure of the Quality Assurance unit to perform periodic audit trail reviews of electronic data. These issues suggest a lack of robust quality systems to ensure product sterility, quality, and data integrity.

## Related Documents

- [483 - 2022-03-09](https://www.keypedia.com/records/483/pharmathen-international-sa/525440ef-3876-4305-bbb1-43cddf39afce)
- [483 - 2025-11-21](https://www.keypedia.com/records/483/pharmathen-international-sa/554ea2e3-0c02-4767-bcbc-671ad0232507)

## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

Company: https://www.keypedia.com/companies/pharmathen-international-sa/4486b3e5-4ce8-40ff-80da-e4364db37198

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1