Sterigenics U.S., LLC
FDA Regulatory Profile
Sterigenics U.S., LLC has 0 FDA recalls, 69 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jul 30, 2026 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| 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 | 69 | Nov 9, 2026 | Newest record Oct 28, 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 |
|---|
Sterigenics Us
Same company group | 0 | 0 | 75 | 0 | — |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jul 30, 2026 | Vernon, CA | Drugs | Voluntary Action Indicated (VAI) | 2011171 |
| Jun 24, 2026 | Queensbury, NY | Devices | No Action Indicated (NAI) | 1000138054 |
| Jun 4, 2026 | Gurnee, IL | Devices | No Action Indicated (NAI) | 3000215273 |
| Aug 6, 2025 | Ontario, CA | Biologics | No Action Indicated (NAI) | 1000160458 |
| Dec 17, 2024 | Schaumburg, IL | Devices | Voluntary Action Indicated (VAI) | 1420032 |
| Sep 26, 2024 | Corona, CA | Biologics | No Action Indicated (NAI) | 1000306431 |
| Jul 11, 2024 | Mulberry, FL | Devices | Voluntary Action Indicated (VAI) | 1000114185 |
| Aug 15, 2023 | Rockaway, NJ | Devices | No Action Indicated (NAI) | 2219920 |
| Jul 21, 2023 | Vernon, CA | Devices | No Action Indicated (NAI) | 2011171 |
| Mar 7, 2023 | Salt Lake City, UT | Devices | No Action Indicated (NAI) | 1721676 |
| Feb 18, 2022 | Vernon, CA | Drugs | No Action Indicated (NAI) | 2011171 |
| Feb 16, 2022 | Corona, CA | Devices | No Action Indicated (NAI) | 1000306431 |
| Nov 3, 2021 | Corona, CA | Drugs | No Action Indicated (NAI) | 1000306431 |
| Jun 25, 2021 | Santa Teresa, NM | Drugs | No Action Indicated (NAI) | 1721686 |
| Jun 10, 2021 | Queensbury, NY | Devices | Voluntary Action Indicated (VAI) | 1000138054 |
| Mar 2, 2020 | Rockaway, NJ | Veterinary | No Action Indicated (NAI) | 2219920 |
| Feb 27, 2020 | Vernon, CA | Devices | No Action Indicated (NAI) | 2011171 |
| Feb 27, 2020 | Vernon, CA | Devices | No Action Indicated (NAI) | 2011171 |
| Feb 25, 2020 | Gurnee, IL | Devices | No Action Indicated (NAI) | 3000215273 |
| Oct 29, 2019 | Salt Lake City, UT | Devices | No Action Indicated (NAI) | 1721676 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 2011171 | Vernon, CA | 10 | Jul 30, 2026 |
| FEI 1000138054 | Queensbury, NY | 8 | Jun 24, 2026 |
| FEI 3000215273 | Gurnee, IL | 6 | Jun 4, 2026 |
| FEI 1000160458 | Ontario, CA | 3 | Aug 6, 2025 |
| FEI 1420032 | Schaumburg, IL | 6 | Dec 17, 2024 |
| FEI 1000306431 | Corona, CA | 11 | Sep 26, 2024 |
| FEI 1000114185 | Mulberry, FL | 7 | Jul 11, 2024 |
| FEI 2219920 | Rockaway, NJ | 6 | Aug 15, 2023 |
| FEI 1721676 | Salt Lake City, UT | 6 | Mar 7, 2023 |
| FEI 1721686 | Santa Teresa, NM | 6 | Jun 25, 2021 |