FDA Inspection
Sunstar Americas, Inc.Sunstar Americas, Inc. – FDA Inspection, Feb 10, 2023
Record Details
This FDA Inspection record concerns Sunstar Americas, Inc., with an inspection on February 10, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · df22bee1-1a02-4a89-8d16-102700a6a05a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1199742
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sunstar Americas, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 6, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 16, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 3, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 20, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sunstar Americas, Inc.
- FDA Inspection 1135892 - 2021-02-18
- FDA Inspection 985191 - 2016-06-06
- FDA Inspection 907857 - 2014-12-16
- FDA Inspection 857393 - 2013-12-03
- FDA Inspection 759343 - 2011-12-20
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