FDA Inspection
Sterilization Services of GASterilization Services of GA – FDA Inspection, Nov 3, 2017
Record Details
This FDA Inspection record concerns Sterilization Services of GA, with an inspection on November 3, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ba81f8d7-b84a-4978-8b09-bad13bda0fb3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030657
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.40Procedures not adequately established or maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sterilization Services of GA
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 25, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 19, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 14, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 30, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sterilization Services of GA
- FDA Inspection 1236641 - 2024-03-25
- FDA Inspection 872199 - 2014-03-19
- FDA Inspection 760412 - 2011-12-14
- FDA Inspection 620966 - 2009-09-30
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