FDA Inspection 1258996 — Natural Hope Herbals, LLC
The FDA completed an inspection of Natural Hope Herbals, LLC on January 23, 2025 in Millersburg, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 23, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Millersburg, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15953 | 21 CFR 111.113(a)(1) | Quality control production, process control; material review, disposition |
| 15981 | 21 CFR 111.123(a)(5) | Quality control operations - reprocessing |
| 16001 | 21 CFR 111.130(a) | Quality control returned dietary supplement; material review, disposition |
| 22840 | 21 CFR 111.35(b) | Make and keep records - equipment and utensils |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22854 | 21 CFR 111.83(b) | Reserve sample - container-closure system |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22915 | 21 CFR 111.570(b) | Records - written procedures; product complaint |