Gauss Surgical, Inc. – FDA Inspection, Jul 18, 2019

Record Details

This FDA Inspection record concerns Gauss Surgical, Inc., with an inspection on July 18, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company: Gauss Surgical, Inc.
Inspection Date: July 18, 2019
Product Type: Devices
Office: Center for Devices and Radiological Health
People: Creighton T. Tuzon (Issuing Officer)
Marlo-Ian M. Alintanahin (Issuing Officer)
Stephen C. Smith (FDA Associated Person)

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ID · 221e5da2-8a62-42a9-8499-800cd531b227

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1096683
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
21 CFR 820.86Acceptance status

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FDA Inspection

Gauss Surgical, Inc.July 18, 2019