FDA Inspection 892752 — Carroll-Baccari Inc
The FDA completed an inspection of Carroll-Baccari Inc on August 27, 2014 in Flat Rock, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 27, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Flat Rock, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |