Domino S.R.L. FDA Record
Domino S.R.L. has 0 FDA recalls, 6 inspections, 2 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Domino S.R.L., the most recent on Jan 19, 2017.
- Latest inspection
- Sep 23, 2025 · NAI
- Latest 510(k)
- Sep 21, 2007
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 2 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 2 | 0 | 1 | 0 | 0 |
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Domino S.R.L. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Jan 19, 2017 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 23, 2025 | Saint Peters, MO | Food/Cosmetics | No Action Indicated (NAI) | 3004305284 |
| Dec 19, 2024 | Codogne', Italy | Devices | No Action Indicated (NAI) | 3006153348 |
| Sep 14, 2017 | Codogne', Italy | Devices | Voluntary Action Indicated (VAI) | 3006153348 |
| Mar 8, 2017 | Saint Peters, MO | Food/Cosmetics | No Action Indicated (NAI) | 3004305284 |
| Jun 5, 2014 | Codogne', Italy | Devices | Voluntary Action Indicated (VAI) | 3006153348 |
| May 26, 2010 | Saint Peters, MO | Food/Cosmetics | No Action Indicated (NAI) | 3004305284 |
- 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 1 compliance action under Domino S.R.L.: warning letters, injunctions and seizures. It came from FDA's Center for Tobacco Products, which regulates tobacco retailers and manufacturers. It is not a drug, medical device or food manufacturing action.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004305284 | Saint Peters, MO | 3 | Sep 23, 2025 |
| FEI 3006153348 | Codogne', Italy | 3 | Dec 19, 2024 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K071431 | GLOBUS GENESY 1100 STIMULATOR | Sep 21, 2007 |
| K061632 | GLOBUS PREMIUM MUSCLE STIMULATOR | Apr 30, 2007 |
Domino S.R.L. and the FDA: common questions
Has Domino S.R.L. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Domino S.R.L.. The most recent is dated Jan 19, 2017.
Has Domino S.R.L. received an FDA Form 483?
FDA has not published a Form 483 for "Domino S.R.L." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Domino S.R.L.?
The most recent FDA inspection on file ended Sep 23, 2025 at Saint Peters, MO and was classified NAI. FDA has 6 inspections of Domino S.R.L. on file.
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