FDA Inspection
Carrashield Labs Inc.Carrashield Labs Inc. – FDA Inspection, Apr 29, 2026
Record Details
This FDA Inspection record concerns Carrashield Labs Inc., with an inspection on April 29, 2026, issued by the Florida District Office, covering medical devices & rad health.
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ID · af532be4-0f41-425c-b636-a44b492f5c4c
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1317200
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 801.20(a)Label to bear a unique device identifier
- ISO 13485:2016 Clause 7.3.3Design and development inputs do not include all requirements
- ISO 13485:2016 Clause 7.3.6Design and development verification not performed
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Other FDA inspections of Carrashield Labs Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 19, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Carrashield Labs Inc.
- FDA Inspection 1018360 - 2017-06-19
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