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SunOpta Grains And Foods, Inc. FDA Inspection Record

FEI 1000520242 · Inspections, Form 483s, warning letters and import refusals

SunOpta Grains And Foods, Inc. is an FDA-inspected facility (FEI 1000520242) located in Alexandria, MN, US. RegDataLab tracks 10 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Sep 3, 2026: No Action Indicated (NAI)
Inspections on record
10 (7 VAI, 3 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Sep 3, 2026No Action Indicated (NAI)No citations listed
Sep 29, 2023Voluntary Action Indicated (VAI)Startup - commercial sterility (21 CFR 113.40(g)(1)(ii)(A))
Jan 18, 2023No Action Indicated (NAI)No citations listed
Jun 30, 2017Voluntary Action Indicated (VAI)Manufacturing, processing, packing, holding - Controls (21 CFR 117.80(c))
Adjusted to agree with TID (21 CFR 113.40(g)(1)(i)(B)(3))
Process adherence (21 CFR 108.35(c)(3)(i))
May 16, 2014Voluntary Action Indicated (VAI)Q.C. instrument accuracy, maintenance (21 CFR 110.40(f))
Buildings/sanitary (21 CFR 110.35(a))
Storage requirements (21 CFR 110.35(b)(2))
Failure to clean - general (21 CFR 110.35(d))
and 3 more
May 12, 2014No Action Indicated (NAI)No citations listed
Feb 15, 2013Voluntary Action Indicated (VAI)Q.C. instrument accuracy, maintenance (21 CFR 110.40(f))
Cleaning and sanitizing operations (21 CFR 110.35(a))
Manufacturing conditions (21 CFR 110.80(b)(2))
Recorder range, chart graduations (21 CFR 113.40(g)(1)(i)(B)(1))
and 2 more
Mar 21, 2012Voluntary Action Indicated (VAI)No accurate TID (21 CFR 113.40(g)(1)(i)(A))
Present each sterilizer, accurate (21 CFR 113.40(g)(1)(i)(B))
Nov 10, 2010Voluntary Action Indicated (VAI)Buildings/good repair (21 CFR 110.35(a))
TID not reference instrument (21 CFR 113.40(g)(1)(i)(A)(5))
Adjusted to agree with TID (21 CFR 113.40(g)(1)(i)(B)(3))
TID reading, holding tube outlet - frequency (21 CFR 113.40(g)(1)(ii)(E))
and 1 more
Nov 20, 2009Voluntary Action Indicated (VAI)Critical factors record - frequency (21 CFR 113.40(g)(4))
TID not reference instrument (21 CFR 113.40(g)(1)(i)(A)(5))
Adjusted to agree with TID (21 CFR 113.40(g)(1)(i)(B)(3))
TID reading, holding tube outlet - frequency (21 CFR 113.40(g)(1)(ii)(E))

FDA record score

5 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

7 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAISep 29, 20236 x 0.63.6
Inspection classified VAIJun 30, 20176 x 0.251.5
Inspection classified VAIMay 16, 201410 years or older, so it adds no points0
Inspection classified VAIFeb 15, 201310 years or older, so it adds no points0
Inspection classified VAIMar 21, 201210 years or older, so it adds no points0
Inspection classified VAINov 10, 201010 years or older, so it adds no points0
Inspection classified VAINov 20, 200910 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
SunOpta Grains And Foods, Inc.
Location
Alexandria, MN (US)
Source
inspections

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.