FDA Inspection
Cooler Heads Care, Inc.Cooler Heads Care, Inc. – FDA Inspection, Apr 5, 2024
Record Details
This FDA Inspection record concerns Cooler Heads Care, Inc., with an inspection on April 5, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a4875b27-080a-4cb8-8f55-4ae662a77a7d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1235740
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Cooler Heads Care, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2026 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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