Tomz Corporation FDA Record
Tomz Corporation has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Tomz Corporation" is on file.
- Latest inspection
- Mar 28, 2025 · 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 |
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 | 0 | 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 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 28, 2025 | Berlin, CT | Devices | No Action Indicated (NAI) | 1000514086 |
| Mar 3, 2017 | Berlin, CT | Devices | No Action Indicated (NAI) | 1000514086 |
- 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 1000514086 | Berlin, CT | 2 | Mar 28, 2025 |
Tomz Corporation and the FDA: common questions
Has Tomz Corporation received an FDA warning letter?
No FDA warning letter addressed to the name "Tomz Corporation" 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 Tomz Corporation received an FDA Form 483?
FDA has not published a Form 483 for "Tomz Corporation" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Tomz Corporation?
The most recent FDA inspection on file ended Mar 28, 2025 at Berlin, CT and was classified NAI. FDA has 2 inspections of Tomz Corporation on file.
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