867922
raphe Generics Corp — FEI 3009569638
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 21, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Garland, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1581 | 21 CFR 110.37(e) | Running water at suitable temperature |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |