FDA Inspection 742543 — Euro USA, LLC
The FDA completed an inspection of Euro USA, LLC on September 15, 2011 in Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 15, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 6005 | 21 CFR 123.6(c)(6) | Verification procedures - adequacy |
| 6008 | 21 CFR 123.8(a)(3) | Verification - record review - frequency |
| 6010 | 21 CFR 123.8(a)(3)(i) | Monitoring record review adequacy |
| 6012 | 21 CFR 123.8(a)(3)(iii) | Calibration record review adequacy |
| 6018 | 21 CFR 123.7(a) | Corrective action per predetermined plan |
| 904 | 21 CFR 123.6(b) | No HACCP plan |
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |
| 961 | 21 CFR 123.6(c)(3) | Critical limits |
| 963 | 21 CFR 123.6(c)(5) | Corrective action plan |