796232
United Laboratories Manufacturing, LLC — FEI 3006056935
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 16, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Carrollton, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15525 | 21 CFR 111.30(b) | Equipment - automated - suitability |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15554 | 21 CFR 111.260(j)(2)(ii) | Batch record - initials; verifying weight |
| 15602 | 21 CFR 111.160(e) | Packaging, labels - mix-ups |
| 15607 | 21 CFR 111.165(c)(2) | Product received - quality control; documentation; specs |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15821 | 21 CFR 111.60(a) | Production, in- process control system - design, quality |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15983 | 21 CFR 111.123(a)(7) | Quality control operations - finished batch, specifications |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |