FDA Inspection 850225 — American Herbal Laboratories, Inc
The FDA completed an inspection of American Herbal Laboratories, Inc on September 25, 2013 in Rosemead, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 25, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Rosemead, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15754 | 21 CFR 111.210(a) | Master manufacturing record - dietary ingredients |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15874 | 21 CFR 111.75(c)(4) | Documentation - specifications met; basis, quality control |