FDA Inspection
Sterigenics US LLCSterigenics US LLC – FDA Inspection, Mar 17, 2017
Record Details
This FDA Inspection record concerns Sterigenics US LLC, with an inspection on March 17, 2017, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · e6786e34-b629-4dbf-ac61-2c377d61ccde
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005678
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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Other FDA inspections of Sterigenics US LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 4, 2026 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 16, 2023 | Not classified | Chicago District Office | |
| February 25, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 6, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 7, 2011 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Sterigenics US LLC
- FDA Inspection 1321316 - 2026-06-04
- FDA Inspection 1217959 - 2023-08-16
- FDA Inspection 1119620 - 2020-02-25
- FDA Inspection 858025 - 2013-12-06
- FDA Inspection 756199 - 2011-12-07
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