FDA Inspection
SunOpta Grains and Foods Inc.SunOpta Grains and Foods Inc. – FDA Inspection, Mar 9, 2017
Record Details
This FDA Inspection record concerns SunOpta Grains and Foods Inc., with an inspection on March 9, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Brandon J. Brookens
- Brian R. Yaun (Company Rep)
- Maureen A. Wentzel (Issuing Officer)
- Melissa M. Schafer (Investigator)
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ID · 7cc7344d-aff1-48a9-a64c-6b1be54b5ca9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006243
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 113.40(g)(1)(i)(F)Unauthorized flow adjustments
- 21 CFR 113.100(b)Review of processing and production records
- 21 CFR 113.40(g)(1)(i)(B)Aseptic processing: recorder, permanent record
- 21 CFR 113.40(g)(1)(i)(B)(3)Adjusted to agree with TID
- 21 CFR 114.100(b)Maintenance of processing and production records
- 21 CFR 113.40(g)(1)(i)(C)Range
- 21 CFR 113.40(g)(2)(ii)(C)Operating conditions observed, recorded - frequency
- 21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls
- 21 CFR 117.93Storage and Distribution
- 21 CFR 117.80(c)(8)Process control - Foreign objects
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Other FDA inspections of SunOpta Grains and Foods Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2025 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| July 19, 2022 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 12, 2016 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| June 30, 2014 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| December 11, 2013 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for SunOpta Grains and Foods Inc.
- FDA Inspection 1255598 - 2025-08-15
- FDA Inspection 1175298 - 2022-07-19
- FDA Inspection 973200 - 2016-05-12
- FDA Inspection 885220 - 2014-06-30
- FDA Inspection 857561 - 2013-12-11
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