FDA Inspection 1326762 — iCRco, Inc.
The FDA completed an inspection of iCRco, Inc. on Jul 17, 2026 in Goleta, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 17, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Goleta, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23145 | ISO 13485:2016 Clause 7.4.1 | Records of supplier (re)evaluation, selection, and monitoring not maintained |
| 23174 | ISO 13485:2016 Clause 7.5.6 | Records of validation of processes and necessary actions not maintained |