FDA Inspection
GATT TECHNOLOGIES BVGATT TECHNOLOGIES BV – FDA Inspection, Aug 21, 2025
Record Details
This FDA Inspection record concerns GATT TECHNOLOGIES BV, with an inspection on August 21, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · a228f9ec-0fee-444e-97e6-5d31bb516f5d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1279274
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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