FDA Inspection 1019366 — Mizkan America, Inc.
The FDA completed an inspection of Mizkan America, Inc. on March 30, 2017 in Owensboro, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 30, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Owensboro, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1330 | 21 CFR 113.100(a) | Process records - forms missing information |
| 18151 | 21 CFR 117.40(f) | Instruments and Controls |
| 2503 | 21 CFR 113.40(e)(2)(iii) | Unauthorized adjustment |
| 4181 | 21 CFR 113.89 | Process deviation identification |