James Joye, D.O. – FDA Inspection, Mar 31, 2017

Record Details

This FDA Inspection record concerns James Joye, D.O., with an inspection on March 31, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: James Joye, D.O.
Inspection Date: March 31, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Humberto Z. Gomez (Company Rep)

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ID · 7d174e6b-abda-45c5-8f95-c296491650d1

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1026766
FDA center: Medical Devices & Rad Health
Project area: Bioresearch Monitoring
Outcome: Form 483 issued

FDA Citations

21 CFR 812.150(a)(1)Investigator report of unanticipated adverse effects
21 CFR 812.140(d)Record retention inadequate

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FDA Inspection

James Joye, D.O.March 31, 2017