Company
United StatesOtologics LLC, Boulder, CO – FDA Inspections
Inspection records and compliance data for Otologics LLC in Boulder, Colorado. 2 FDA inspections on record (1 OAI), last inspected January 26, 2011.
Company Profile
This profile covers Otologics LLC based in Boulder, Colorado, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 19, 2009. Last inspected January 26, 2011.
Most cited issue areas
- Record retention inadequate1 inspection
- Sponsor correspondence records inadequate1 inspection
- Sponsor device disposition records inadequate1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 26, 2011 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 713634 |
| November 19, 2009 | OAI | Medical Devices & Rad Health · Bioresearch Monitoring | 633639 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Otologics LLC
FEI Number
3003590807
Address
5445 Airport Blvd, Boulder, Colorado 80301, United States
Country
United States
ID: e1ff76f9-5372-47d8-ac4f-8a4fb0eb685b