FDA Inspection
Synergy Health AST LLCSynergy Health AST LLC – FDA Inspection, Jan 5, 2011
Record Details
This FDA Inspection record concerns Synergy Health AST LLC, with an inspection on January 5, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Synergy Health AST LLC
- Inspection Date
- January 5, 2011
- Product Type
- Devices
View Company Profile
ID · ba4028a6-6988-45b0-8ee9-079337c8ee58
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 704530
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 1271.230(a)Process validation procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Synergy Health AST LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 30, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 2, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 10, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 10, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 23, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Synergy Health AST LLC
- FDA Inspection 1051030 - 2018-04-30
- FDA Inspection 1020211 - 2017-08-02
- FDA Inspection 930402 - 2015-06-10
- FDA Inspection 849490 - 2013-09-10
- FDA Inspection 817800 - 2013-01-23
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