483
Prothya Biosolutions BelgiumFDA 483 - Prothya Biosolutions Belgium
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Record Details
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.
- Company
- Prothya Biosolutions Belgium
- Product Type
- Biologics
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