FDA Inspection 1116908 — Inverelle dba Ultra-Life, Inc.
The FDA completed an inspection of Inverelle dba Ultra-Life, Inc. on February 5, 2020 in Carlyle, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 5, 2020
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Carlyle, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15493 | 21 CFR 111.25(b) | Procedures - calibrating automated, mechanical equip |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |
| 16043 | 21 CFR 111.503 | Written procedures - returned dietary supplement; destroyed |