FDA Inspection
ONERA BVONERA BV – FDA Inspection, Mar 20, 2025
Record Details
This FDA Inspection record concerns ONERA BV, with an inspection on March 20, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 7d284939-30f5-48e5-a1ce-17dedecd3098
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1264193
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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