St. Jude Medical IESD
Form 483 issued February 17, 2017 · Sylmar, California
- Inspection
- Feb 7 – Feb 17, 2017
- Investigators
- Alford R. Taylor· Leonard H. Lavi
- Observations
- 6
- Pages
- 4
- FEI number
- 2017865
In short: On February 17, 2017, FDA issued a Form 483 with 6 observations to St. Jude Medical IESD in Sylmar, California (FEI 2017865) after an inspection that ran Feb 7 – Feb 17, 2017. The investigators were Alford R. Taylor and Leonard H. Lavi. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and design controls account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Procedures for management review have…
- 03
A correction or removal, conducted to reduce a risk to health posed by a device, was…
- 04
Products that do not conform to specifications are not…
This inspection in context
Alford R. Taylor
1 document · 2017
Cites 820.30(f) (design controls) more than any other section. Most of their documents are for sites in California.
The firmSt. Jude Medical IESD history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at St. Jude Medical IESD?
FDA listed 6 observations on this Form 483, mostly about cAPA, design controls and management controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected St. Jude Medical IESD?
Alford R. Taylor and Leonard H. Lavi are named on this Form 483, for the inspection of Feb 7 – Feb 17, 2017. Each investigator has a profile showing what they cite most.
When was St. Jude Medical IESD inspected by FDA?
The inspection ran Feb 7 – Feb 17, 2017, and the Form 483 is dated February 17, 2017.
How do I get the full Form 483 for St. Jude Medical IESD?
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.