St. Jude Medical IESD
Form 483 issued October 17, 2020 · Sylmar, California
- Inspection
- Oct 17, 2020
- Investigator
- Sean T. Creighton
- Observations
- 16
- Pages
- 9
- FEI number
- 2017865
In short: On October 17, 2020, FDA issued a Form 483 with 16 observations to St. Jude Medical IESD in Sylmar, California (FEI 2017865) after an inspection that ran Oct 17, 2020. The investigator was Sean T. Creighton. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and capa account for 11 of 16 observations.
Most cited: 21 CFR 820.30 (7×) · 820.100 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your design verification activities were inadequate in that you failed to validate 3 test methods you…
- 02
You failed to follow your written test procedure during design verification testing of (b)(4) test, which…
- 03
You conducted your Durata(D esign verification to verify the' (b) (4) (bl f-l), __ _ _…
- 04
your design verification and it was inadequate in that: a. It did not include predetermined acceptance…
This inspection in context
Sean T. Creighton
9 documents · 2006–2020
Cites 820.30 (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 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at St. Jude Medical IESD?
FDA listed 16 observations on this Form 483, mostly about design controls, cAPA 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?
Sean T. Creighton is named on this Form 483, for the inspection of Oct 17, 2020. Each investigator has a profile showing what they cite most.
When was St. Jude Medical IESD inspected by FDA?
The inspection ran Oct 17, 2020, and the Form 483 is dated October 17, 2020.
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.