FDA Inspection 993327 — Herbal Doctor Remedies
The FDA completed an inspection of Herbal Doctor Remedies on November 28, 2016 in Monterey Park, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 28, 2016
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Monterey Park, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15734 | 21 CFR 111.360 | Manufacturing operations - sanitation |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |