1119901
Omega Alpha Pharmaceuticals — FEI 3010129381
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 20, 2020
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Scarborough (Canada)
Citations
| ID | CFR | Description |
|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15542 | 21 CFR 111.260(b) | Batch record - date, time; maintenance |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15554 | 21 CFR 111.260(j)(2)(ii) | Batch record - initials; verifying weight |
| 15555 | 21 CFR 111.260(j)(2)(iii) | Batch record - initials; component |
| 15556 | 21 CFR 111.260(j)(2)(iv) | Batch record - initials; verifying component |
| 15557 | 21 CFR 111.260(k) | Batch record - packaging, labeling |
| 15559 | 21 CFR 111.260(k)(1) | Batch record - identifier; labels |
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15665 | 21 CFR 111.303 | Written procedures - tests, examinations; specifications met |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15864 | 21 CFR 111.75(a)(2)(ii)(C) | Documentation - qualify supplier |