675429
United Laboratories Manufacturing, LLC — FEI 3006056935
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 12, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carrollton, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15883 | 21 CFR 111.75(i) | Corrective action plan |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |