FDA Inspection
Peter KosekPeter Kosek – FDA Inspection, Apr 21, 2017
Record Details
This FDA Inspection record concerns Peter Kosek, with an inspection on April 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 456046f8-6f18-4f10-a0d1-f8612def9f30
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1010961
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
- 21 CFR 50.25(a)(8)Participation; refusal and discontinuance
- 21 CFR 50.25(a)(2)Reasonably foreseeable risks or discomforts
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