FDA Inspection
Siesta Medical, Inc.Siesta Medical, Inc. – FDA Inspection, Dec 15, 2022
Record Details
This FDA Inspection record concerns Siesta Medical, Inc., with an inspection on December 15, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Siesta Medical, Inc.
- Inspection Date
- December 15, 2022
- Product Type
- Devices
View Company Profile
ID · e8e3fe26-8e0f-4674-b5e8-54ec40590032
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1193401
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Siesta Medical, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2025 | Not classified | San Francisco District Office | |
| July 28, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Siesta Medical, Inc.
- FDA Inspection 1295672 - 2025-09-30
- FDA Inspection 888058 - 2014-07-28
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