FDA Inspection
Hutchens Thomas MDHutchens Thomas MD – FDA Inspection, Sep 13, 2018
Record Details
This FDA Inspection record concerns Hutchens Thomas MD, with an inspection on September 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 792c8dab-987b-48b7-a27d-1b962382b6bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065782
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 812.140(a)(3)(ii)Investigator adverse effect records inadequate
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