FDA Inspection 644078 — Synapse Biomedical Inc
The FDA completed an inspection of Synapse Biomedical Inc on Feb 11, 2010 in Oberlin, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 11, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Oberlin, OH (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2940 | 21 CFR 812.43(c)(4)(i) | No investigation agreement statement of commitment |
| 3049 | 21 CFR 812.150(b)(5) | Sponsor progress reports for significant risk study |
| 7006 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement |