FDA Inspection 1317200 — Carrashield, Labs Inc.
The FDA completed an inspection of Carrashield, Labs Inc. on April 29, 2026 in Saint Petersburg, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 29, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Saint Petersburg, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 23104 | ISO 13485:2016 Clause 7.3.3 | Design and development inputs do not include all requirements |
| 23114 | ISO 13485:2016 Clause 7.3.6 | Design and development verification not performed |