FDA Inspection 772202 — Endogastric Solutions, Inc.
The FDA completed an inspection of Endogastric Solutions, Inc. on February 29, 2012 in San Mateo, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 29, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- San Mateo, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14516 | 21 CFR 812.25(e) | Sponsor's lack of written monitoring procedures |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2933 | 21 CFR 812.43(a) | Investigator(s) not qualified |
| 2939 | 21 CFR 812.43(c)(3) | No research termination info in investigator agreement |
| 2956 | 21 CFR 812.46(c) | No approval to resume significant risk study |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |