FDA Inspection
Richard Buch, MDRichard Buch, MD – FDA Inspection, Dec 12, 2017
Record Details
This FDA Inspection record concerns Richard Buch, MD, with an inspection on December 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b0a3edde-e699-447e-acc3-48de0365e4ec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034599
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 812.140(a)(1)Investigator correspondence records inadequate
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