FDA Inspection
Anthony HoffmanAnthony Hoffman – FDA Inspection, May 5, 2015
Record Details
This FDA Inspection record concerns Anthony Hoffman, with an inspection on May 5, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Anthony Hoffman
- Inspection Date
- May 5, 2015
- Product Type
- Devices
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ID · cd44de85-ca85-4866-8224-a66e6b8d6f2f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 923836
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 812.150(a)(1)Investigator report of unanticipated adverse effects
- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
- 21 CFR 50.20Understandable language
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
- 21 CFR 812.110(d)Inadequate financial disclosure by investigator
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