St. Jude Medical
FDA inspection history in Atlanta, Georgia, 2015
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2015: one warning letter and one amended 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One warning letter and one amended 483, at Atlanta, Georgia.
Cited most
Across all St. Jude Medical observations on file
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.22Quality audit2
- 21 CFR 820.70(a)Production and process controls2
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?1
The complete St. Jude Medical file.
All 2 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
Atlanta, Georgia
One warning letter and one amended 483 · 2015 · 12 observations
Latest: Warning letter, Sep 30, 2015 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-09-30 | Warning letter Warning letter | Atlanta, Georgia | — | $99 |
| 2015-07-06 | Amended 483 Amended 483 | Atlanta, Georgia | 12 | $99 |
Investigators on these documents
FEI number 3004936110 · most recent document Sep 30, 2015
About St. Jude Medical
How many FDA Form 483s has St. Jude Medical received?
FDA Intel has 1 Form 483 on file for St. Jude Medical; the most recent is dated Jul 6, 2015.
When was St. Jude Medical last inspected by FDA?
The most recent FDA inspection document on file for St. Jude Medical is a Form 483 dated Jul 6, 2015, for the site in Atlanta, Georgia.
What did FDA cite at St. Jude Medical?
The regulations cited most in the observations on file for St. Jude Medical are 21 CFR 820.100(a) (Corrective and preventive action), 2 times; 21 CFR 820.22 (Quality audit), 2 times; 21 CFR 820.70(a) (Production and process controls), 2 times.
Has St. Jude Medical received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for St. Jude Medical; the most recent is dated Sep 30, 2015.