Company
United StatesAzena Medical, LLC, Walnut Creek, CA – FDA Inspections
Inspection records and compliance data for Azena Medical, LLC in Walnut Creek, California. 1 FDA inspection on record, 1 Form 483, last inspected October 06, 2017.
Company Profile
This profile covers Azena Medical, LLC based in Walnut Creek, California, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected October 6, 2017.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Investigation of device failures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 6, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1028264 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Azena Medical, LLC
FEI Number
3011877721
Address
3021 Citrus Cir Ste 180, Walnut Creek, California 94598, United States
Country
United States
ID: 8b238c31-0f28-4e4c-89fb-1fc758b643f5