BLS Systems Ltd FDA Record
BLS Systems Ltd has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "BLS Systems Ltd" is on file.
- Latest inspection
- Aug 10, 2016 · OAI
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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 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 10, 2016 | Oakville, Canada | Devices | Official Action Indicated (OAI) | 3000213164 |
- 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 3000213164 | Oakville, Canada | 1 | Aug 10, 2016 |
BLS Systems Ltd and the FDA: common questions
Has BLS Systems Ltd received an FDA warning letter?
No FDA warning letter addressed to the name "BLS Systems Ltd" 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 BLS Systems Ltd received an FDA Form 483?
FDA has not published a Form 483 for "BLS Systems Ltd" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect BLS Systems Ltd?
The most recent FDA inspection on file ended Aug 10, 2016 at Oakville, Canada and was classified OAI. FDA has 1 inspection of BLS Systems Ltd on file, 1 of them classified OAI (official action indicated).
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