Company
United StatesAvacen Inc., Carlsbad, CA – FDA Inspections
Inspection records and compliance data for Avacen Inc. in Carlsbad, California. 4 FDA inspections on record (1 OAI), 1 warning letter, last inspected April 12, 2024.
Company Profile
This profile covers Avacen Inc. based in Carlsbad, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 3
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
First inspected July 25, 2013. Last inspected April 12, 2024.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- DHR - not or inadequately maintained1 inspection
- DMR - not or inadequately maintained1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 12, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1236857 |
| July 20, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1146623 |
| April 29, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 972512 |
| July 25, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 842696 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Avacen Inc.
FEI Number
3009668937
Address
6451 El Camino Real Ste C, Carlsbad, California 92009, United States
Country
United States
ID: a1f99653-db69-4e32-85b4-5613bc94ced7