FDA Inspection 633639 — Otologics LLC
The FDA completed an inspection of Otologics LLC on November 19, 2009 in Boulder, CO. 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
- November 19, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Boulder, CO (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2949 | 21 CFR 812.46(a) | Sponsor securing investigator compliance |
| 2991 | 21 CFR 812.140(b)(1) | Sponsor correspondence records inadequate |
| 2992 | 21 CFR 812.140(b)(2) | Sponsor device shipment records inadequate |
| 2993 | 21 CFR 812.140(b)(2) | Sponsor device disposition records inadequate |
| 3007 | 21 CFR 812.140(d) | Record retention inadequate |