Intuitive Surgical, Inc.

Form 483FOIA Uncovered

Sunnyvale, California, United StatesFEI 3001675293Issued August 27, 2021

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3001675293.

Observations6

Issue DateAugust 27, 2021

StatusNo Warning Letter

Related Inspections10

Establishment Details

Firm: Intuitive Surgical, Inc.
Location: Sunnyvale, California, United States
FEI Number: 3001675293
Product Type: Devices
Issue Date: August 27, 2021
Country: United States

Inspection History, 2010 to 2025

NAI4

VAI4

OAI2

NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.

Act on This Form 483

FDA Inspection ReadinessSee how your operations would hold up to the same scrutiny.CAPA & InvestigationsScore how you would investigate and close findings like these.Talk to a SpecialistWalk through these observations with a ComplianceQuest expert.

Intuitive Surgical, Inc. FDA Form 483, Sunnyvale, California, August 27, 2021