FDA Inspection
Creation Technologies Wisconsin IncCreation Technologies Wisconsin Inc – FDA Inspection, Jul 20, 2023
Record Details
This FDA Inspection record concerns Creation Technologies Wisconsin Inc, with an inspection on July 20, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d1f8d2ac-e6a8-42f7-a815-7a00b07e469f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210669
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.72(a)Equipment control activity documentation
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