Company
United StatesAdvanced Bionics, LLC, Valencia, CA – FDA Inspections
Inspection records and compliance data for Advanced Bionics, LLC in Valencia, California. 5 FDA inspections on record, 1 Form 483, last inspected May 08, 2019.
Company Profile
This profile covers Advanced Bionics, LLC based in Valencia, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected April 26, 2012. Last inspected May 8, 2019.
Most cited issue areas
- Design verification - documentation1 inspection
- Nonconforming product control1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 8, 2019 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1090274 |
| September 28, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1067389 |
| September 23, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 943363 |
| May 16, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 832131 |
| April 26, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 778606 |
FDA documents
Form 483s (1)
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Company Information
Name
Advanced Bionics, LLC
FEI Number
1000220815
Address
28515 Westinghouse Pl, Valencia, California 91355, United States
Country
United States
ID: a85a3594-768e-4f01-a859-ee4a874576fe