FDA Inspection 620661 — Prothya Biosolutions Netherlands B.V.
The FDA completed an inspection of Prothya Biosolutions Netherlands B.V. on September 15, 2009 in Amsterdam. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 15, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Amsterdam (Netherlands)