FDA Inspection
Fujirebio Europe N.V.Fujirebio Europe N.V. – FDA Inspection, Nov 10, 2016
Record Details
This FDA Inspection record concerns Fujirebio Europe N.V., with an inspection on November 10, 2016, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Fujirebio Europe N.V.
- Inspection Date
- November 10, 2016
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · f5e94a4e-d2ef-438f-a3b0-54b81c24f766
Inspection Facts
- Inspection number
- 992892
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Fujirebio Europe N.V.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2019 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Fujirebio Europe N.V.
- FDA Inspection 1096452 - 2019-06-06
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