FDA Inspection 650354 — Carolina Liquid Chemistries Corp
The FDA completed an inspection of Carolina Liquid Chemistries Corp on March 2, 2010 in Brea, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 2, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Brea, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3138 | 21 CFR 820.130 | Packaging |
| 3151 | 21 CFR 820.180 | Legibility |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3370 | 21 CFR 820.198(a)(2) | Oral complaints |
| 3381 | 21 CFR 820.198(e)(7) | Corrective action taken |
| 4189 | 21 CFR 820.198(a) | General |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 9117 | 21 CFR 809.10(a)(9)(i) | Lot/Control Numbers - multiple unit product |
| 9176 | 21 CFR 809.20(b) | Compliance with GMP |