FDA Inspection
Sterigenics U.S., LLCSterigenics U.S., LLC – FDA Inspection, Aug 15, 2023
Record Details
This FDA Inspection record concerns Sterigenics U.S., LLC, with an inspection on August 15, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a8afcf21-10f9-4587-916a-dc4441770d89
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1215298
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.72(b)Remedial action
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Sterigenics U.S., LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2020 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| October 31, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 13, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 14, 2012 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| November 20, 2009 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Sterigenics U.S., LLC
- FDA Inspection 1123488 - 2020-03-02
- FDA Inspection 1081756 - 2018-10-31
- FDA Inspection 969813 - 2016-05-13
- FDA Inspection 810569 - 2012-12-14
- FDA Inspection 629535 - 2009-11-20
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