# FDA 483 - Polpharma Biologics S.A - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/polpharma-biologics-sa/65f8ead4-a181-44df-83a1-b88e007e7454

> FDA 483 for Polpharma Biologics S.A on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Polpharma Biologics S.A
- Product Type: biologics
- Office Name: Division of Advertising & Promotion 
- Summary: The FDA inspection of Polpharma Biologics S.A. in Gdańsk, Poland, revealed multiple significant deficiencies in their drug substance manufacturing processes. Key issues include inadequate process validation, insufficient cleaning and disinfection controls, and a lack of proper documentation for changes and investigations. These observations indicate a need for comprehensive improvements in quality systems and operational procedures.

## Related Documents

- [483 - 2022-03-22](https://www.globalkeysolutions.net/records/483/polpharma-biologics-sa/9e4721e6-5964-43e8-9054-8fbf62ac1050)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)
- [Jacek Cieslak](https://www.globalkeysolutions.net/people/jacek-cieslak/81b12add-49f1-4dfd-bcb1-60bc5b212b68)
- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.globalkeysolutions.net/companies/polpharma-biologics-sa/cbcf90aa-e0dc-4cd8-90ab-3389315441d8

Office: https://www.globalkeysolutions.net/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0