Sometech Corporation FDA Record
- Latest inspection VAI · Jul 5, 2017
- Last warning letter 2012
Sometech Corporation has 0 FDA recalls, 2 inspections, 4 510(k) clearances and 2 compliance actions on record. FDA has issued 2 warning letters to Sometech Corporation, the most recent on Nov 26, 2012.
- Latest inspection
- Jul 5, 2017 · VAI
- Latest 510(k)
- May 1, 2013
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 4 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 2 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 2 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Reviewing Sometech Corporation as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Sometech Corporation yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Sometech Corporation FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Nov 26, 2012 · Record page | |||
| Apr 6, 2011 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 5, 2017 | Lawrenceville, GA | Devices | Voluntary Action Indicated (VAI) | 3003998292 |
| Nov 4, 2010 | Seoul, Korea (The Republic Of) | Devices | Official Action Indicated (OAI) | 3002992007 |
- 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.
Compliance Actions
FDA's compliance actions data lists 2 compliance actions under Sometech Corporation: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003998292 | Lawrenceville, GA | 1 | Jul 5, 2017 |
| FEI 3002992007 | Seoul, Korea (The Republic Of) | 1 | Nov 4, 2010 |
Sometech Corporation and the FDA: common questions
Has Sometech Corporation received an FDA warning letter?
Yes. FDA has issued 2 warning letters to Sometech Corporation. The most recent is dated Nov 26, 2012.
Has Sometech Corporation received an FDA Form 483?
FDA has not published a Form 483 for "Sometech Corporation" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Sometech Corporation?
The most recent FDA inspection on file ended Jul 5, 2017 at Lawrenceville, GA and was classified VAI. FDA has 2 inspections of Sometech Corporation on file, 1 of them classified OAI (official action indicated).
Need more than this page shows? Ask about Sometech Corporation in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.