# FDA 483 - Prothya Biosolutions Belgium - Unknown Date

Source: https://www.keypedia.com/records/483/prothya-biosolutions-belgium/a1d4878a-10f8-490a-b9f7-110e4e026090

> FDA 483 for Prothya Biosolutions Belgium on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prothya Biosolutions Belgium
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Plasma Industries Belgium SCRL, a biologics manufacturer in Brussels, Belgium, from March 12-16, 2018, revealed significant deficiencies. Observations included inadequate cleaning validation, untimely and insufficient deviation investigations, and incomplete change control processes. The firm also lacked proper preventative maintenance and exhibited poor facility sanitation, indicating a need for improved quality systems.

## Related Officers

- [investigator](https://www.keypedia.com/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)
- [CSO](https://www.keypedia.com/people/mihaly-s-ligmond/2904ef70-a757-49c7-9ac4-a2c07ee36001)

Company: https://www.keypedia.com/companies/prothya-biosolutions-belgium/14cc76aa-03ad-49c2-aec8-4af088fd986a

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4