FDA Inspection
Global Cooling IncGlobal Cooling Inc – FDA Inspection, Feb 21, 2014
Record Details
This FDA Inspection record concerns Global Cooling Inc, with an inspection on February 21, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Global Cooling Inc
- Inspection Date
- February 21, 2014
- Product Type
- Devices
View Company Profile
ID · accd7a4e-45d0-4e15-9910-3c66658c14a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 869320
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 803.17Lack of Written MDR Procedures
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