FDA Inspection
Cool Renewal LLCCool Renewal LLC – FDA Inspection, Oct 13, 2016
Record Details
This FDA Inspection record concerns Cool Renewal LLC, with an inspection on October 13, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Bonnie E. Conley (Issuing Officer)
- Mary A. Millner
View Company Profile
ID · 68d130f3-9093-4d03-b3a8-8d3d07b6d201
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988229
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
Other FDA inspections of Cool Renewal LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2017 | Not classified | New Orleans District Office |
Other documents for Cool Renewal LLC
- FDA Inspection 1055729 - 2017-12-06
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