Intuitive Surgical, Inc.
Form 483 issued May 30, 2013 · Sunnyvale, California
- Inspection
- Apr 1 – May 30, 2013
- Investigator
- Mary R. Hole
- Observations
- 4
- Pages
- 4
- FEI number
- 3001675293
In short: On May 30, 2013, FDA issued a Form 483 with 4 observations to Intuitive Surgical, Inc. in Sunnyvale, California (FEI 3001675293) after an inspection that ran Apr 1 – May 30, 2013. The investigator was Mary R. Hole. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 806.10 (reports of corrections and removals).
At a glance
CAPA and design controls account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
A correction or removal, conducted to reduce a risk to health posed by a device, was…
- 02
Illnesses or injuries that have occurred with use of devices subject to corrections or removals…
- 03
Procedures for design change have…
- 04
Design input requirements were…
This inspection in context
Mary R. Hole
7 documents · 2013–2017
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmIntuitive Surgical, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 806.10(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intuitive Surgical, Inc.?
FDA listed 4 observations on this Form 483, mostly about cAPA and design controls. The most-cited regulation is 21 CFR 806.10 (reports of corrections and removals). The opening words of each observation are shown on this page.
Who inspected Intuitive Surgical, Inc.?
Mary R. Hole is named on this Form 483, for the inspection of Apr 1 – May 30, 2013. Each investigator has a profile showing what they cite most.
When was Intuitive Surgical, Inc. inspected by FDA?
The inspection ran Apr 1 – May 30, 2013, and the Form 483 is dated May 30, 2013.
How do I get the full Form 483 for Intuitive Surgical, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.