1078187
ORI Bionature SDN BHD — FEI 3012605896
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 19, 2018
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Puchong (Malaysia)
Citations
| ID | CFR | Description |
|---|
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15559 | 21 CFR 111.260(k)(1) | Batch record - identifier; labels |
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15753 | 21 CFR 111.210(b) | Master manufacturing record - list components |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |