FDA Inspection
Intuitive Surgical, Inc.Intuitive Surgical, Inc. – FDA Inspection, Nov 5, 2025
Record Details
This FDA Inspection record concerns Intuitive Surgical, Inc., with an inspection on November 5, 2025, issued by the San Francisco District Office, covering medical devices & rad health.
- Company
- Intuitive Surgical, Inc.
- Inspection Date
- November 5, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 095e5feb-e0f0-48d4-b053-f850078251bd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1276877
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
6- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Intuitive Surgical, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| December 21, 2023 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 14, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 27, 2021 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 26, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 14, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Intuitive Surgical, Inc.
- FDA Inspection 1227392 - 2023-12-21
- FDA Inspection 1225346 - 2023-12-14
- FDA Inspection 1149960 - 2021-08-27
- FDA Inspection 1020267 - 2017-04-26
- FDA Inspection 945068 - 2015-10-14
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