FDA Inspection 1065932 — Verlytix LLC
The FDA completed an inspection of Verlytix LLC on Sep 11, 2018 in Mequon, WI. 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)
- End Date
- Sep 11, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Mequon, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15581 | 21 CFR 111.155(c)(3) | Quality control - components, approve, release |
| 15755 | 21 CFR 111.205(c) | Master manufacturing record: readily available |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |