ONETIK FDA Record
ONETIK has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "ONETIK" is on file.
- Latest inspection
- Feb 17, 2015 · 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 | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Reviewing ONETIK 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 ONETIK yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 17, 2015 | Macaye, France | Food/Cosmetics | No Action Indicated (NAI) | 3004265685 |
| Dec 2, 2011 | Macaye, France | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3004265685 |
- 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 3004265685 | Macaye, France | 2 | Feb 17, 2015 |
ONETIK and the FDA: common questions
Has ONETIK received an FDA warning letter?
No FDA warning letter addressed to the name "ONETIK" 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 ONETIK received an FDA Form 483?
FDA has not published a Form 483 for "ONETIK" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect ONETIK?
The most recent FDA inspection on file ended Feb 17, 2015 at Macaye, France and was classified NAI. FDA has 2 inspections of ONETIK on file.
Need more than this page shows? Ask about ONETIK 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.