FDA Inspection
Intuitive Surgical, Inc.Intuitive Surgical, Inc. – FDA Inspection, Aug 27, 2021
Record Details
This FDA Inspection record concerns Intuitive Surgical, Inc., with an inspection on August 27, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Intuitive Surgical, Inc.
- Inspection Date
- August 27, 2021
- Product Type
- Devices
View Company Profile
ID · fd5705e7-1f51-4740-9e75-d87a0db8800b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1149960
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.198(a)Complaints
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.180Availability
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Other FDA inspections of Intuitive Surgical, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| November 5, 2025 | OAI | San Francisco District Office | Compliance: Medical Devices |
| 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 |
| 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 1276877 - 2025-11-05
- FDA Inspection 1227392 - 2023-12-21
- FDA Inspection 1225346 - 2023-12-14
- FDA Inspection 1020267 - 2017-04-26
- FDA Inspection 945068 - 2015-10-14
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