KBD, Inc. – FDA Inspection, Nov 8, 2019

Record Details

This FDA Inspection record concerns KBD, Inc., with an inspection on November 8, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company: KBD, Inc.
Inspection Date: November 8, 2019
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 7d4df0f6-5129-465c-947e-a060f0fb8bc4

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1109206
FDA center: Medical Devices & Rad Health
Project area: Radiation Control and Health Safety Act

FDA Citations

21 CFR 1010.2(b)Certification label or tag
21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.40Procedures not adequately established or maintained
21 CFR 1040.20(d)(1)(i)Label - Warning statement
21 CFR 1040.20(d)(2)(iii)"Use ONLY with timer" label
21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.20(c)Management review - Lack of or inadequate procedures

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Other FDA inspections of KBD, Inc.

Date	Classification	Office	Project area
December 23, 2016	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
August 22, 2012	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
July 25, 2011	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices