SMC Ltd. Medical Manufacturing Division FDA Record
SMC Ltd. Medical Manufacturing Division has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "SMC Ltd. Medical Manufacturing Division" is on file.
- Latest inspection
- Oct 27, 2010 · NAI
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 |
|---|---|---|---|---|
| Oct 27, 2010 | Somerset, WI | Devices | No Action Indicated (NAI) | 3004595311 |
- 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 3004595311 | Somerset, WI | 1 | Oct 27, 2010 |
SMC Ltd. Medical Manufacturing Division and the FDA: common questions
Has SMC Ltd. Medical Manufacturing Division received an FDA warning letter?
No FDA warning letter addressed to the name "SMC Ltd. Medical Manufacturing Division" 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 SMC Ltd. Medical Manufacturing Division received an FDA Form 483?
FDA has not published a Form 483 for "SMC Ltd. Medical Manufacturing Division" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect SMC Ltd. Medical Manufacturing Division?
The most recent FDA inspection on file ended Oct 27, 2010 at Somerset, WI and was classified NAI. FDA has 1 inspection of SMC Ltd. Medical Manufacturing Division on file.
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