FDA Inspection
Cooler Heads Care, Inc.Cooler Heads Care, Inc. – FDA Inspection, Aug 6, 2026
Record Details
This FDA Inspection record concerns Cooler Heads Care, Inc., with an inspection on August 6, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cooler Heads Care, Inc.
- Inspection Date
- August 6, 2026
- Product Type
- Devices
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ID · ca5c765d-d2fa-45f9-88a4-4b2c327284f1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1329686
- Project area
- Compliance: Devices
FDA Citations
3- ISO 13485:2016 Clause 7.1Records of supplier (re)evaluation, selection, and monitoring not maintained
- ISO 13485:2016 Clause 8.5.1Nonconforming product not adequately evaluated
- ISO 13485:2016 Clause 8.2.1Information gathered in feedback process not used as input into risk management
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Other FDA inspections of Cooler Heads Care, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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