Company
United StatesCooler Heads Care, Inc., San Diego, CA – FDA Inspections
Inspection records and compliance data for Cooler Heads Care, Inc. in San Diego, California. 2 FDA inspections on record, last inspected August 06, 2026.
Company Profile
This profile covers Cooler Heads Care, Inc. based in San Diego, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected April 5, 2024. Last inspected August 6, 2026.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Information gathered in feedback process not used as input into risk management1 inspection
- Nonconforming product not adequately evaluated1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 6, 2026 | VAI | · Compliance: Devices | 1329686 |
| April 5, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1235740 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Cooler Heads Care, Inc.
FEI Number
3021619527
Address
610 Gateway Center Way Ste G, San Diego, California 92102, United States
Country
United States
ID: 269d0cee-32a2-4a29-8b69-32201fe120f2