FDA Inspection
Sterigenics US, LLCSterigenics US, LLC – FDA Inspection, Jun 7, 2012
Record Details
This FDA Inspection record concerns Sterigenics US, LLC, with an inspection on June 7, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sterigenics US, LLC
- Inspection Date
- June 7, 2012
- Product Type
- Drugs
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ID · ff7b2548-8d5c-42f9-a729-e77d9949b4c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 784882
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.194(b)Test method modification records not maintained
- 21 CFR 211.110(b)In-process materials specifications
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Other FDA inspections of Sterigenics US, LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 13, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 18, 2023 | Not classified | San Francisco District Office | |
| April 4, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 7, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 5, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Sterigenics US, LLC
- FDA Inspection 1331328 - 2026-08-13
- FDA Inspection 1215620 - 2023-08-18
- FDA Inspection 1009381 - 2017-04-04
- FDA Inspection 986254 - 2016-09-07
- FDA Inspection 925161 - 2015-05-05
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