FDA Inspection 1022299 — Sabatino North America, LLC
The FDA completed an inspection of Sabatino North America, LLC on August 21, 2017 in West Haven, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 21, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- West Haven, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15001 | 21 CFR 113.60(a)(1) | Closure examinations - corrective actions taken and recorded |
| 1597 | 21 CFR 110.37(b)(3) | As source of contamination |
| 1639 | 21 CFR 113.100(b) | Entry not timely |
| 1641 | 21 CFR 113.100(b) | Review not timely |
| 1763 | 21 CFR 110.35(b)(1) | Safe and adequate for use |
| 2169 | 21 CFR 113.40(b)(10) | Operator check, record, frequency |
| 3071 | 21 CFR 114.80(a)(1) | Scheduled process |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 3866 | 21 CFR 113.60(a)(1)(i)(a) | Required can seam measurements (micrometer) |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |