Janssen Biotech, Inc.
Janssen Biotech, Inc. has 0 FDA recalls, 21 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jul 29, 2025 · VAI
Newer recall under related name Ethicon: Sep 8, 2026, Z-0153-2027.
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 21 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|---|---|---|---|---|
| Ethicon | 77 | 208 | 15 | 0 | Sep 8, 2026 (Z-0153-2027) |
| Johnson And Johnson Surgical Vision | 18 | 4 | 9 | 0 | Jul 31, 2026 (Z-3064-2026) |
| Synthes (Usa) Products | 164 | 45 | 7 | 0 | Feb 25, 2026 (Z-1703-2026) |
| Cerenovus | 1 | 10 | 11 | 0 | Oct 2, 2025 (Z-0434-2026) |
| Ethicon Endo-Surgery | 54 | 184 | 8 | 0 | Sep 11, 2025 (Z-0147-2026) |
| Johnson And Johnson Vision Care | 10 | 12 | 4 | 0 | Jun 12, 2025 (Z-2163-2025) |
| Ethicon Endo Surgery | 4 | 2 | 2 | 0 | Mar 7, 2025 (Z-1516-2025) |
| Biosense Webster | 33 | 76 | 7 | 0 | Jan 5, 2025 (Z-1205-2025) |
| Ethicon Sarl, A Johnson And Johnson | 2 | 0 | 2 | 0 | Jun 11, 2024 (Z-2407-2024) |
| Depuy Orthopaedics | 155 | 210 | 11 | 2 | Mar 12, 2024 (Z-1456-2024) |
| Depuy Spine | 36 | 71 | 9 | 0 | May 20, 2022 (Z-1324-2022) |
| Janssen Pharmaceuticals | 4 | 0 | 32 | 2 | Oct 23, 2018 (D-0218-2019) |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 29, 2025 | Malvern, PA | Drugs | Voluntary Action Indicated (VAI) | 3001610451 |
| Mar 10, 2025 | Malvern, PA | Biologics | No Action Indicated (NAI) | 3001610451 |
| Jan 17, 2025 | Horsham, PA | Drugs | No Action Indicated (NAI) | 3006473233 |
| Sep 24, 2024 | Horsham, PA | Drugs | No Action Indicated (NAI) | 3006473233 |
| Nov 30, 2018 | Malvern, PA | Drugs | No Action Indicated (NAI) | 3001610451 |
| Jun 22, 2018 | Horsham, PA | Drugs | No Action Indicated (NAI) | 3006473233 |
| Mar 5, 2018 | Malvern, PA | Drugs | Voluntary Action Indicated (VAI) | 3001610451 |
| Nov 21, 2017 | Malvern, PA | Drugs | Voluntary Action Indicated (VAI) | 3001610451 |
| Feb 27, 2017 | Malvern, PA | Drugs | No Action Indicated (NAI) | 3001610451 |
| Feb 25, 2016 | Horsham, PA | Drugs | Voluntary Action Indicated (VAI) | 3006473233 |
| Nov 24, 2015 | Horsham, PA | Drugs | No Action Indicated (NAI) | 3006473233 |
| Aug 19, 2015 | Malvern, PA | Drugs | No Action Indicated (NAI) | 3001610451 |
| Sep 24, 2014 | Malvern, PA | Drugs | Voluntary Action Indicated (VAI) | 3001610451 |
| Sep 25, 2012 | Malvern, PA | Drugs | No Action Indicated (NAI) | 3001610451 |
| Jun 15, 2012 | Malvern, PA | Drugs | Voluntary Action Indicated (VAI) | 3001610451 |
| May 20, 2011 | Malvern, PA | Drugs | Voluntary Action Indicated (VAI) | 3001610451 |
| Apr 14, 2011 | Horsham, PA | Drugs | Voluntary Action Indicated (VAI) | 3006473233 |
| Oct 26, 2010 | Malvern, PA | Drugs | Voluntary Action Indicated (VAI) | 3001610451 |
| Oct 2, 2009 | Horsham, PA | Drugs | Voluntary Action Indicated (VAI) | 3006473233 |
| Aug 18, 2009 | Malvern, PA | Drugs | Voluntary Action Indicated (VAI) | 3001610451 |
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3001610451 | Malvern, PA | 14 | Jul 29, 2025 |
| FEI 3006473233 | Horsham, PA | 7 | Jan 17, 2025 |