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FDA Inspection
•Global Services Group•December 16, 2008

Global Services Group – FDA Inspection, Dec 16, 2008

Record Details

This FDA Inspection record concerns Global Services Group, with an inspection on December 16, 2008, issued by the Center for Devices and Radiological Health, covering devices.

Company
Global Services Group
Inspection Date
December 16, 2008
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · b5fafd7a-e045-4365-a9fd-247d20c51f7c

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
552501
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

6
  1. 21 CFR 820.20(d)Quality plan
  2. 21 CFR 820.40Lack of procedures, or not maintained
  3. 21 CFR 820.22Quality audits - Lack of or inadequate procedures
  4. 21 CFR 820.30(a)Design control - no procedures
  5. 21 CFR 820.100(b)Procedures
  6. 21 CFR 820.20(a)Quality policy and objectives

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