Esm Technologies FDA Record
Esm Technologies has 0 FDA recalls, 7 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Esm Technologies" is on file.
- Latest inspection
- May 1, 2025 · NAI
- Latest 510(k)
- Dec 26, 2007
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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 | 7 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 1, 2025 | Carthage, MO | Food/Cosmetics | No Action Indicated (NAI) | 3026841237 |
| Mar 21, 2023 | Carthage, MO | Food/Cosmetics | No Action Indicated (NAI) | 3004443481 |
| Jul 29, 2021 | Carthage, MO | Food/Cosmetics | No Action Indicated (NAI) | 3010633240 |
| Jun 15, 2016 | Carthage, MO | Food/Cosmetics | No Action Indicated (NAI) | 3004443481 |
| Jan 30, 2014 | Carthage, MO | Food/Cosmetics | No Action Indicated (NAI) | 3004443481 |
| Jan 30, 2014 | Carthage, MO | Food/Cosmetics | No Action Indicated (NAI) | 3010633240 |
| Nov 4, 2010 | Madison, WI | Devices | No Action Indicated (NAI) | 3006369351 |
- 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 3026841237 | Carthage, MO | 1 | May 1, 2025 |
| FEI 3004443481 | Carthage, MO | 3 | Mar 21, 2023 |
| FEI 3010633240 | Carthage, MO | 2 | Jul 29, 2021 |
| FEI 3006369351 | Madison, WI | 1 | Nov 4, 2010 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K072231 | THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE) | Dec 26, 2007 |
| K051764 | T-PLATE ANTERIOR FIXATION SYSTEM | Jul 13, 2005 |
Esm Technologies and the FDA: common questions
Has Esm Technologies received an FDA warning letter?
No FDA warning letter addressed to the name "Esm Technologies" 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 Esm Technologies received an FDA Form 483?
FDA has not published a Form 483 for "Esm Technologies" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Esm Technologies?
The most recent FDA inspection on file ended May 1, 2025 at Carthage, MO and was classified NAI. FDA has 7 inspections of Esm Technologies on file.
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