# FDA 483 - Intuitive Surgical, Inc. - November 05, 2025

Source: https://www.globalkeysolutions.net/records/483/intuitive-surgical-inc/be41201e-33fd-4a82-8e0f-87625b3e33bc

> FDA 483 for Intuitive Surgical, Inc. on November 05, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intuitive Surgical, Inc.
- Inspection Date: 2025-11-05
- Product Type: device
- Office Name: San Francisco District Office
- Summary: Intuitive Surgical, Inc. in Sunnyvale, CA, was inspected from 10/14/2025 to 11/5/2025, revealing significant deficiencies in its quality system. The inspection found inadequate procedures for corrective and preventive actions, design verification, risk analysis, and purchasing controls, leading to multiple product recalls and unreported field actions. Additionally, the firm failed to submit Medical Device Reports within the required 30-day timeframe, indicating a systemic failure to ensure product safety and regulatory compliance.

## Related Documents

- [WARNING_LETTER - 2013-05-30](https://www.globalkeysolutions.net/records/warning_letter/intuitive-surgical-inc/cfd95f15-db91-4600-a204-7d66594ec298)
- [483 - 2013-05-30](https://www.globalkeysolutions.net/records/483/intuitive-surgical-inc/b4234888-7638-4b8a-9121-7fa77e8e621e)
- [483 - 2020-03-06](https://www.globalkeysolutions.net/records/483/intuitive-surgical-inc/83171c7b-3c5e-4b20-9e59-25937b39127b)
- [483 - 2021-08-27](https://www.globalkeysolutions.net/records/483/intuitive-surgical-inc/983c7973-fe89-4610-8845-0f8a99212d37)
- [483 - 2023-12-14](https://www.globalkeysolutions.net/records/483/intuitive-surgical-inc/5ebe9d89-9bfc-4a76-a3ab-929c8f1101c5)

## Related Officers

- [Kenya Destin](https://www.globalkeysolutions.net/people/kenya-destin/1a367d64-8171-4dfd-bb1f-78d8b96a99f5)
- [Chad E. Schmear](https://www.globalkeysolutions.net/people/chad-e-schmear/275a4c57-d288-46f9-8257-64fcd96159ce)
- [Karen M. Cruz Arenas](https://www.globalkeysolutions.net/people/karen-m-cruz-arenas/6c698301-84ca-4ba7-a79c-309721db2f1b)

Company: https://www.globalkeysolutions.net/companies/intuitive-surgical-inc/2dea1052-5e1b-4f51-b3e3-6792452d36de

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df