FDA Inspection 949069 — B-R Herbals, LLC
The FDA completed an inspection of B-R Herbals, LLC on October 16, 2015 in Northfield, NH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 16, 2015
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Northfield, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15545 | 21 CFR 111.260(e) | Batch record - component; identity, weight |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |