Surpass, Inc. – FDA Inspection, Dec 7, 2017

Record Details

This FDA Inspection record concerns Surpass, Inc., with an inspection on December 7, 2017, issued by the Minneapolis District Office, covering medical devices & rad health.

Company: Surpass, Inc.
Inspection Date: December 7, 2017
Product Type: Medical Devices & Rad Health
Office: Minneapolis District Office
Person: Denise L. Burosh (FDA Associated Person)

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ID · 90167850-3757-47ac-93a9-a8ddfe988aa8

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1034099
FDA center: Medical Devices & Rad Health
Project area: Project Evaluation: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 58.130(a)Conduct: in accordance with protocol
21 CFR 58.29(a)Personnel: education, training, experience
21 CFR 58.63(a)Equipment: calibration
21 CFR 58.63(b)Equipment: maintenance SOPs

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FDA Inspection

Surpass, Inc.December 7, 2017