FDA Inspection 1173371 — iCRco, Inc.
The FDA completed an inspection of iCRco, Inc. on Jul 1, 2022 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 1, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Goleta, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21424 | 21 CFR 820.120(b) | Labeling inspection - UDI |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |