FDA Inspection
Synapse Biomedical IncSynapse Biomedical Inc – FDA Inspection, Feb 11, 2010
Record Details
This FDA Inspection record concerns Synapse Biomedical Inc, with an inspection on February 11, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Synapse Biomedical Inc
- Inspection Date
- February 11, 2010
- Product Type
- Devices
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ID · 7a9a3eca-55be-48e3-a62d-2a3c4748da9b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 644078
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.43(c)(4)(i)No investigation agreement statement of commitment
- 21 CFR 812.43(c)(5)No financial disclosure info in investigator agreement
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.150(b)(5)Sponsor progress reports for significant risk study
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Synapse Biomedical Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 7, 2020 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 5, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 5, 2012 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Synapse Biomedical Inc
- FDA Inspection 1195865 - 2023-01-18
- FDA Inspection 1130955 - 2020-10-07
- FDA Inspection 906473 - 2014-12-05
- FDA Inspection 807042 - 2012-11-05
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