FDA Inspection 1322752 — KeriCure Inc.
The FDA completed an inspection of KeriCure Inc. on June 11, 2026 in Land O Lakes, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 11, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Land O Lakes, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23021 | ISO 13485:2016 Clause 4.1.3 | QMS process records not established or maintained |
| 23088 | ISO 13485:2016 Clause 7.1 | Records of risk management activities in product realization not maintained |
| 23174 | ISO 13485:2016 Clause 7.5.6 | Records of validation of processes and necessary actions not maintained |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |