Paceline Inc. – FDA Inspection, May 21, 2014

Record Details

This FDA Inspection record concerns Paceline Inc., with an inspection on May 21, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: Paceline Inc.
Inspection Date: May 21, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · bef384cf-165d-44f5-8c78-bb6537909a4d

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 881568
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.198(c)Investigation of device failures
21 CFR 820.198(a)Lack of or inadequate complaint procedures

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FDA Inspection

Paceline Inc.May 21, 2014