Company
United StatesAerin Medical, Inc., Sunnyvale, CA – FDA Inspections
Inspection records and compliance data for Aerin Medical, Inc. in Sunnyvale, California. 2 FDA inspections on record, 1 Form 483, last inspected September 22, 2025.
Company Profile
This profile covers Aerin Medical, Inc. based in Sunnyvale, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected October 27, 2017. Last inspected September 22, 2025.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Training records1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 22, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1284330 |
| October 27, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1030795 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Aerin Medical, Inc.
FEI Number
3011625895
Address
232 E Caribbean Dr, Sunnyvale, California 94089, United States
Country
United States
ID: 77377dad-3be0-4381-8706-9250c94a29e3