FDA Inspection
Synergy Health AST LLCSynergy Health AST LLC – FDA Inspection, Aug 2, 2017
Record Details
This FDA Inspection record concerns Synergy Health AST LLC, with an inspection on August 2, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f907a22d-f51b-4167-bd06-498aebaea0dc
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1020211
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate 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 |
| 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 |
| January 5, 2011 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Synergy Health AST LLC
- FDA Inspection 1051030 - 2018-04-30
- FDA Inspection 930402 - 2015-06-10
- FDA Inspection 849490 - 2013-09-10
- FDA Inspection 817800 - 2013-01-23
- FDA Inspection 704530 - 2011-01-05
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