AHA Hyperbarics USA Corp. – FDA Inspection, Apr 8, 2019

Record Details

This FDA Inspection record concerns AHA Hyperbarics USA Corp., with an inspection on April 8, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company: AHA Hyperbarics USA Corp.
Inspection Date: April 8, 2019
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Andrew J. Garufi (Issuing Officer)

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ID · f03c225e-195d-4e87-bba3-3e88027010c3

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1085534
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.72(a)Equipment control activity documentation

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FDA Inspection

AHA Hyperbarics USA Corp.April 8, 2019