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FDA Inspection
•Shenzen Kudos Dental Dev. Co. Ltd•August 24, 2016

Shenzen Kudos Dental Dev. Co. Ltd – FDA Inspection, Aug 24, 2016

Record Details

This FDA Inspection record concerns Shenzen Kudos Dental Dev. Co. Ltd, with an inspection on August 24, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company
Shenzen Kudos Dental Dev. Co. Ltd
Inspection Date
August 24, 2016
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · d92c8f11-23bd-456c-883f-143e8405f40f

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
988017
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

4
  1. 21 CFR 820.20(d)Quality plan
  2. 21 CFR 820.198(a)Complaints
  3. 21 CFR 820.20(a)Management ensuring quality policy is understood
  4. 21 CFR 820.25(a)Personnel

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Shenzen Kudos Dental Dev. Co. Ltd

1
DateClassificationOfficeProject area
August 23, 2010VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Shenzen Kudos Dental Dev. Co. Ltd
  • FDA Inspection 678610 - 2010-08-23

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