1018490
Deserving Health International Corp — FEI 3012271380
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 14, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Richmond (Canada)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1266 | 21 CFR 211.42(d) | Penicillin processing area not kept separate |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1725 | 21 CFR 211.134(c) | Examinations documented |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4328 | 21 CFR 211.122(a) | Written procedures not followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |