St. Jude Medical IESD
FDA inspection history in Sylmar, California, 2013 to 2020
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2013: one warning letter; 2017: one Form 483; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One warning letter, at Sylmar, California.
- 2017One Form 483, at Sylmar, California.
- 2020One Form 483, at Sylmar, California.
- 2020The longest 483 on file: 11 observations over 9 pages at Sylmar, California.
Cited most
Across all St. Jude Medical IESD observations on file
- 21 CFR 820.30Design controls9
- 21 CFR 820.100Corrective and preventive action4
- 21 CFR 820.25Personnel2
- 21 CFR 806.10(a)(1)Reports of corrections and removals1
- 21 CFR 820.198Complaint files1
The complete St. Jude Medical IESD file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Sylmar, California
Two Form 483s and one warning letter · 2013 to 2020 · 17 observations
Latest: Form 483, Oct 17, 2020 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-10-17 | 483 Form 483 | Sylmar, California | 11 | $99 |
| 2017-02-17 | 483 Form 483 | Sylmar, California | 6 | $99 |
| 2013-03-15 | Warning letter Warning letter | Sylmar, California | — | $99 |
Investigators on these documents
Alford R. Taylor (1)Leonard H. Lavi (1)Sean T. Creighton (1)
FEI number 2017865 · most recent document Oct 17, 2020
About St. Jude Medical IESD
How many FDA Form 483s has St. Jude Medical IESD received?
FDA Intel has 2 Form 483s on file for St. Jude Medical IESD; the most recent is dated Oct 17, 2020.
When was St. Jude Medical IESD last inspected by FDA?
The most recent FDA inspection document on file for St. Jude Medical IESD is a Form 483 dated Oct 17, 2020, for the site in Sylmar, California.
What did FDA cite at St. Jude Medical IESD?
The regulations cited most in the observations on file for St. Jude Medical IESD are 21 CFR 820.30 (Design controls), 9 times; 21 CFR 820.100 (Corrective and preventive action), 4 times; 21 CFR 820.25 (Personnel), 2 times.
Has St. Jude Medical IESD received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for St. Jude Medical IESD; the most recent is dated Mar 15, 2013.