FDA Inspection
Otologics LLCOtologics LLC – FDA Inspection, Nov 19, 2009
Record Details
This FDA Inspection record concerns Otologics LLC, with an inspection on November 19, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Otologics LLC
- Inspection Date
- November 19, 2009
- Product Type
- Devices
View Company Profile
ID · 7ad0ab82-59b4-4751-a869-7bc80795bada
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 633639
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 812.46(a)Sponsor securing investigator compliance
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.140(b)(2)Sponsor device disposition records inadequate
- 21 CFR 812.140(b)(2)Sponsor device shipment records inadequate
- 21 CFR 812.140(b)(1)Sponsor correspondence records inadequate
- 21 CFR 812.140(d)Record retention inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Otologics LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2011 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Otologics LLC
- FDA Inspection 713634 - 2011-01-26
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.