Arthur R. Cabrera, M.D. – FDA Inspection, May 16, 2023

Record Details

This FDA Inspection record concerns Arthur R. Cabrera, M.D., with an inspection on May 16, 2023, issued by the Center for Devices and Radiological Health, covering devices.

Company: Arthur R. Cabrera, M.D.
Inspection Date: May 16, 2023
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Theressa B. Smith (Issuing Officer)

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ID · beef4ffc-a482-4c83-a4ae-a6331d6c2107

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1205599
FDA center: Medical Devices & Rad Health
Project area: Bioresearch Monitoring
Outcome: Form 483 issued

FDA Citations

21 CFR 812.2(b)Abbreviated requirements / non-significant risk study
21 CFR 50.20Circumstances of obtaining consent
21 CFR 812.5(a)Label does not contain required information
21 CFR 50.20Circumstances of obtaining consent
21 CFR 812.2(b)Abbreviated requirements / non-significant risk study
21 CFR 812.5(a)Label does not contain required information

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FDA Inspection

Arthur R. Cabrera, M.D.May 16, 2023