Company
United StatesSiesta Medical, Inc., Los Gatos, CA – FDA Inspections
Inspection records and compliance data for Siesta Medical, Inc. in Los Gatos, California. 3 FDA inspections on record, last inspected September 30, 2025.
Company Profile
This profile covers Siesta Medical, Inc. based in Los Gatos, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected July 28, 2014. Last inspected September 30, 2025.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 30, 2025 | Not classified | Medical Devices & Rad Health | 1295672 |
| December 15, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1193401 |
| July 28, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 888058 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Siesta Medical, Inc.
FEI Number
3008792120
Address
101 Church St, Los Gatos, California 95030, United States
Country
United States
ID: 2193f4d6-5930-4a62-9a8e-d0ac137c2441