FDA Inspection 1034128 — Eidon Inc.
The FDA completed an inspection of Eidon Inc. on December 7, 2017 in Poway, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 7, 2017
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Poway, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15542 | 21 CFR 111.260(b) | Batch record - date, time; maintenance |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15547 | 21 CFR 111.260(g) | Batch record - results; monitoring |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 16008 | 21 CFR 111.135 | Quality control operations - product complaints; investigate |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |