Althea US, Inc. – FDA Inspection, Nov 4, 2016

Record Details

This FDA Inspection record concerns Althea US, Inc., with an inspection on November 4, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company: Althea US, Inc.
Inspection Date: November 4, 2016
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Andrew Saunders

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ID · b71e03ff-0a27-406a-9868-1ffd8da0f265

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 991555
FDA center: Medical Devices & Rad Health
Project area: Radiation Control and Health Safety Act
Outcome: Form 483 issued

FDA Citations

21 CFR 1020.30(d)(1)Report of assembly submitted within 15 days
21 CFR 1020.30(d)Assembling, installing, adjusting, testing

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FDA Inspection

Althea US, Inc.November 4, 2016