FDA Inspection 1229269 — Eden's Answers Inc
The FDA completed an inspection of Eden's Answers Inc on February 9, 2024 in Holmesville, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 9, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Holmesville, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 16001 | 21 CFR 111.130(a) | Quality control returned dietary supplement; material review, disposition |
| 16017 | 21 CFR 111.140(b)(3) | Records - material review, disposition documentation |