FDA Inspection 797456 — Carolon Company
The FDA completed an inspection of Carolon Company on August 6, 2012 in Rural Hall, NC. 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
- August 6, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rural Hall, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3837 | 21 CFR 820.25(b) | Training records |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |