Bite Tech Inc. – FDA Inspection, Apr 11, 2019

Record Details

This FDA Inspection record concerns Bite Tech Inc., with an inspection on April 11, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company: Bite Tech Inc.
Inspection Date: April 11, 2019
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Michael G. Mayfield (Company Rep)

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ID · ec01472e-9f9b-484b-8701-78f6b9680001

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1086050
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 803.17Lack of Written MDR Procedures
21 CFR 820.20(e)Quality System Procedures

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FDA Inspection

Bite Tech Inc.April 11, 2019