FDA Inspection 1288258 — Nature's Elements, Inc.
The FDA completed an inspection of Nature's Elements, Inc. on October 16, 2025 in Bohemia, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 16, 2025
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Bohemia, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15577 | 21 CFR 111.155(b) | Visually examine - supplier's invoice |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 22811 | 21 CFR 111.453 | Written procedures - establish; holding and distribution |
| 22813 | 21 CFR 111.553 | Written procedures - establish; product complaint |
| 22834 | 21 CFR 111.25 | Equipment - establish written procedures |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22900 | 21 CFR 111.403 | Written procedures - establish; packaging & labeling |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |