FDA Inspection 1303142 — Seacole-CRC, LLC
The FDA completed an inspection of Seacole-CRC, LLC on February 13, 2026 in Plymouth, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 13, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Plymouth, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23016 | ISO 13485:2016 Clause 4.1.1 | QMS not documented and maintained adequately |
| 23169 | ISO 13485:2016 Clause 7.5.6 | Procedures for validation of processes not documented |