FDA Inspection
Cenova ABCenova AB – FDA Inspection, May 8, 2025
Record Details
This FDA Inspection record concerns Cenova AB, with an inspection on May 8, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · c89966f5-1e57-4482-a861-1e2590c71365
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1269851
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.184DHR content
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Other FDA inspections of Cenova AB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 18, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 12, 2019 | Not classified | Office of Inspections and Investigations |
Other documents for Cenova AB
- FDA Inspection 1194250 - 2022-11-18
- FDA Inspection 1090521 - 2019-04-12
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