FDA Inspection 1006243 — SunOpta Grains and Foods Inc.
The FDA completed an inspection of SunOpta Grains and Foods Inc. on March 9, 2017 in Allentown, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 9, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Allentown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 16288 | 21 CFR 113.100(b) | Review of processing and production records |
| 16459 | 21 CFR 113.40(g)(1)(i)(B) | Aseptic processing: recorder, permanent record |
| 18148 | 21 CFR 117.37 | Sanitary facilities and controls |
| 18161 | 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls |
| 18163 | 21 CFR 117.80(c)(8) | Process control - Foreign objects |
| 18165 | 21 CFR 117.93 | Storage and Distribution |
| 2848 | 21 CFR 113.40(g)(1)(i)(B)(3) | Adjusted to agree with TID |
| 2852 | 21 CFR 113.40(g)(1)(i)(C) | Range |
| 2860 | 21 CFR 113.40(g)(1)(i)(F) | Unauthorized flow adjustments |
| 2898 | 21 CFR 113.40(g)(2)(ii)(C) | Operating conditions observed, recorded - frequency |
| 3086 | 21 CFR 114.100(b) | Maintenance of processing and production records |