Medmira Laboratories, Inc. FDA Record
Medmira Laboratories, Inc. has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Medmira Laboratories, Inc." is on file.
- Latest inspection
- Jun 4, 2015 · NAI
- Latest 510(k)
- Nov 13, 2000
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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 | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | 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 |
|---|---|---|---|---|
| Jun 4, 2015 | Halifax, Canada | Biologics | No Action Indicated (NAI) | 3003595936 |
| Nov 18, 2011 | Halifax, Canada | Biologics | Voluntary Action Indicated (VAI) | 3003595936 |
| Mar 25, 2010 | Halifax, Canada | Devices | Voluntary Action Indicated (VAI) | 3003595936 |
- 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 3003595936 | Halifax, Canada | 3 | Jun 4, 2015 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K002023 | MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 | Nov 13, 2000 |
Medmira Laboratories, Inc. and the FDA: common questions
Has Medmira Laboratories, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Medmira Laboratories, Inc." 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 Medmira Laboratories, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Medmira Laboratories, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Medmira Laboratories, Inc.?
The most recent FDA inspection on file ended Jun 4, 2015 at Halifax, Canada and was classified NAI. FDA has 3 inspections of Medmira Laboratories, Inc. on file.
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