FDA Inspection
Sterigenics US, LLCSterigenics US, LLC – FDA Inspection, Mar 18, 2009
Record Details
This FDA Inspection record concerns Sterigenics US, LLC, with an inspection on March 18, 2009, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Sterigenics US, LLC
- Inspection Date
- March 18, 2009
- Product Type
- Food/cosmetics
View Company Profile
ID · e669fc15-d6df-44de-8cb0-d89d01c12826
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 570531
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
FDA Citations
5- 21 CFR 110.80(b)(4)Preventive control measures
- 21 CFR 820.70(g)(3)Adjustment
- 21 CFR 820.70(g)(1)Activity documentation
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sterigenics US, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 6, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 7, 2017 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| February 11, 2015 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| November 26, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sterigenics US, LLC
- FDA Inspection 1265113 - 2025-02-28
- FDA Inspection 1017915 - 2017-07-06
- FDA Inspection 1013355 - 2017-04-07
- FDA Inspection 913117 - 2015-02-11
- FDA Inspection 809586 - 2012-11-26
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