Integra Lifesciences Sales Llc FDA Record
Integra Lifesciences Sales Llc has 1 FDA recall, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Integra Lifesciences Sales Llc" is on file.
- Latest recall
- Z-0691-2020 · Class II · Nov 4, 2019
- Latest inspection
- May 13, 2024 · NAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 1 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 1 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0691-2020 | Class II | Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The… | Nov 4, 2019 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 13, 2024 | Cordova, TN | Biologics | No Action Indicated (NAI) | 3014118249 |
| May 26, 2022 | Cordova, TN | Biologics | No Action Indicated (NAI) | 3014118249 |
| Aug 8, 2019 | Cordova, TN | Biologics | Voluntary Action Indicated (VAI) | 3014118249 |
- 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 3014118249 | Cordova, TN | 3 | May 13, 2024 |
Integra Lifesciences Sales Llc and the FDA: common questions
Has Integra Lifesciences Sales Llc received an FDA warning letter?
No FDA warning letter addressed to the name "Integra Lifesciences Sales Llc" 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 Integra Lifesciences Sales Llc received an FDA Form 483?
FDA has not published a Form 483 for "Integra Lifesciences Sales Llc" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Integra Lifesciences Sales Llc?
The most recent FDA inspection on file ended May 13, 2024 at Cordova, TN and was classified NAI. FDA has 3 inspections of Integra Lifesciences Sales Llc on file.
Has Integra Lifesciences Sales Llc had an FDA recall?
Yes. Integra Lifesciences Sales Llc has 1 FDA recall on record. The most recent started Nov 4, 2019.
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