Birth Tissue Recovery LLC
Birth Tissue Recovery LLC has 0 FDA recalls, 15 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jun 17, 2024 · NAI
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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 | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 15 | Nov 13, 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 | 2 | 0 | 0 | 0 | 0 |
| 2022 | 3 | 0 | 0 | 0 | 0 |
| 2021 | 2 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 2 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 17, 2024 | Raleigh, NC | Biologics | No Action Indicated (NAI) | 3014254014 |
| May 9, 2023 | Charlotte, NC | Biologics | No Action Indicated (NAI) | 3011647097 |
| Jan 27, 2023 | Winston Salem, NC | Biologics | No Action Indicated (NAI) | 3009660500 |
| Nov 4, 2022 | Grand Rapids, MI | Biologics | No Action Indicated (NAI) | 3013525989 |
| Oct 13, 2022 | Fayetteville, NC | Biologics | No Action Indicated (NAI) | 3011645769 |
| Jul 27, 2022 | Tucson, AZ | Biologics | No Action Indicated (NAI) | 3017393650 |
| Oct 21, 2021 | Raleigh, NC | Biologics | No Action Indicated (NAI) | 3014254014 |
| Sep 22, 2021 | Hickory, NC | Biologics | No Action Indicated (NAI) | 3016588953 |
| Jan 30, 2019 | Winston Salem, NC | Biologics | No Action Indicated (NAI) | 3009660500 |
| Apr 25, 2018 | Fayetteville, NC | Biologics | No Action Indicated (NAI) | 3011645769 |
| Apr 11, 2018 | Charlotte, NC | Biologics | No Action Indicated (NAI) | 3011647097 |
| Nov 30, 2017 | Grand Rapids, MI | Biologics | No Action Indicated (NAI) | 3013525989 |
| Nov 30, 2016 | Winston Salem, NC | Biologics | No Action Indicated (NAI) | 3009660500 |
| Jun 2, 2016 | Charlotte, NC | Biologics | No Action Indicated (NAI) | 3011647097 |
| Feb 24, 2016 | Fayetteville, NC | Biologics | No Action Indicated (NAI) | 3011645769 |
- 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 3014254014 | Raleigh, NC | 2 | Jun 17, 2024 |
| FEI 3011647097 | Charlotte, NC | 3 | May 9, 2023 |
| FEI 3009660500 | Winston Salem, NC | 3 | Jan 27, 2023 |
| FEI 3013525989 | Grand Rapids, MI | 2 | Nov 4, 2022 |
| FEI 3011645769 | Fayetteville, NC | 3 | Oct 13, 2022 |
| FEI 3017393650 | Tucson, AZ | 1 | Jul 27, 2022 |
| FEI 3016588953 | Hickory, NC | 1 | Sep 22, 2021 |
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