731858
C.J. Labs, Inc. — FEI 3005656496
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 24, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15429 | 21 CFR 111.15(k) | Sanitation supervisors - assigned |
| 15478 | 21 CFR 111.20(f) | Physical plant - bulbs, fixtures, skylights |
| 15481 | 21 CFR 111.23(b) | Records - cleaning, pest control |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15573 | 21 CFR 111.153 | Written procedures - product received; packaging, labeling |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15758 | 21 CFR 111.205(c) | Master manufacturing record: 1 year, 2 years |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15902 | 21 CFR 111.83(b)(4) | Reserve sample - twice the quantity |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 16068 | 21 CFR 111.35(b)(1)(iii) | Equipment, utensils; maintaining, cleaning, sanitizing |
| 16083 | 21 CFR 111.35(b)(6) | Documentation - equipment functions; intended use |