FDA Inspection
Sterigenics US LLCSterigenics US LLC – FDA Inspection, Nov 8, 2011
Record Details
This FDA Inspection record concerns Sterigenics US LLC, with an inspection on November 8, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sterigenics US LLC
- Inspection Date
- November 8, 2011
- Product Type
- Devices
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ID · ef30eabd-8230-4da5-a001-704dcaeb3fbd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 752268
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Sterigenics US LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 28, 2025 | NAI | Postmarket Assurance: Devices | |
| June 22, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 26, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 6, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 19, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sterigenics US LLC
- FDA Inspection 1271833 - 2025-05-28
- FDA Inspection 1173787 - 2022-06-22
- FDA Inspection 1009920 - 2017-04-26
- FDA Inspection 870254 - 2014-03-06
- FDA Inspection 592377 - 2009-06-19
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