FSS, Inc. FDA Inspection Record
FSS, Inc. is an FDA-inspected facility (FEI 3002706429) located in Red Wing, MN, US. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.
What FDA found at this site
- Latest inspection
- Apr 8, 2025: No Action Indicated (NAI)
- Inspections on record
- 7 (1 OAI, 4 VAI, 2 NAI)
- Last OAI inspection
- Jan 9, 2015
- Warning letters
- 1 listed by FDA for this FEI, latest Jun 18, 2015
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 8, 2025 | No Action Indicated (NAI) | No citations listed |
| Oct 20, 2021 | Voluntary Action Indicated (VAI) | No citations listed |
| Dec 11, 2018 | No Action Indicated (NAI) | No citations listed |
| Dec 9, 2015 | Voluntary Action Indicated (VAI) | Q.C. instrument accuracy, maintenance (21 CFR 110.40(f)) Maintenance of equip., utensils, and finished food packaging (21 CFR 110.80(b)(1)) |
| Jan 9, 2015 | Official Action Indicated (OAI) | Q.C. instrument accuracy, maintenance (21 CFR 110.40(f)) Initial temperature of container contents (21 CFR 113.87(c)) Visual indicators not used (21 CFR 113.87(b)) Storage requirements (21 CFR 110.35(b)(2)) and 15 more |
| Apr 9, 2013 | Voluntary Action Indicated (VAI) | Review not timely (21 CFR 113.100(b)) Operator check, record, frequency (21 CFR 113.40(b)(10)) Present each retort, accurate (21 CFR 113.40(e)(2)) Thermal processing - clock time agreement with time of day (21 CFR 113.87(e)) and 1 more |
| May 11, 2012 | Voluntary Action Indicated (VAI) | Container testing (21 CFR 114.80(a)(4)) Code - required elements (21 CFR 114.80(b)) Process filing (21 CFR 108.25(c)(2)) |
FDA record score
2 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.
6 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Oct 20, 2021 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Dec 9, 2015 | 10 years or older, so it adds no points | 0 |
| Warning letter on FDA's dashboard, which does not show close-outs | Jun 18, 2015 | 10 years or older, so it adds no points | 0 |
| Inspection classified OAI | Jan 9, 2015 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Apr 9, 2013 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | May 11, 2012 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- FSS, Inc.
- Location
- Red Wing, MN (US)
- Source
- inspections