FDA Inspection
BRAIN SCIENCE TOOLS BVBRAIN SCIENCE TOOLS BV – FDA Inspection, May 28, 2025
Record Details
This FDA Inspection record concerns BRAIN SCIENCE TOOLS BV, with an inspection on May 28, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 1a92f16a-4a6d-4b84-ba4f-168ac78572d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1271551
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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