STERIS Canada ULC FDA Record
- Latest inspection VAI · Aug 14, 2014
- No warning letters matched by name
STERIS Canada ULC has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "STERIS Canada ULC" is on file.
- Latest inspection
- Aug 14, 2014 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 14, 2014 | Quebec, Canada | Devices | Voluntary Action Indicated (VAI) | 3004097451 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004097451 | Quebec, Canada | 1 | Aug 14, 2014 |
STERIS Canada ULC and the FDA: common questions
Has STERIS Canada ULC received an FDA warning letter?
No FDA warning letter addressed to the name "STERIS Canada ULC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has STERIS Canada ULC received an FDA Form 483?
FDA has not published a Form 483 for "STERIS Canada ULC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect STERIS Canada ULC?
The most recent FDA inspection on file ended Aug 14, 2014 at Quebec, Canada and was classified VAI. FDA has 1 inspection of STERIS Canada ULC on file.
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