Company
United StatesAvantis Medical, Sunnyvale, CA – FDA Inspections
Inspection records and compliance data for Avantis Medical in Sunnyvale, California. 3 FDA inspections on record, last inspected March 10, 2016.
Company Profile
This profile covers Avantis Medical based in Sunnyvale, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected July 24, 2009. Last inspected March 10, 2016.
Most cited issue areas
- Design verification acceptance criteria1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures for labeling1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 10, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 983344 |
| June 8, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 785019 |
| July 24, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 620295 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Avantis Medical
FEI Number
3006315255
Address
263 Santa Ana Ct, Sunnyvale, California 94085, United States
Country
United States
ID: 535ad3e5-2cdd-47e6-aca1-def83ab3050e