Guidant Corporation
FDA inspection history across 2 sites, 2005 to 2006
- 2
- Form 483s
Every document, by year
- Form 483
2005: one Form 483; 2006: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2005–06Two Form 483s, at Saint Paul, Minnesota and St. Paul, Minnesota.
- 2005The longest 483 on file: 9 observations over 7 pages at Saint Paul, Minnesota.
Cited most
Across all Guidant observations on file
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.184Device history record1
- 21 CFR 820.40Document controls1
The complete Guidant 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
St. Paul, Minnesota
One Form 483 · 2006 · 1 observation
Latest: Form 483, Feb 9, 2006 →Saint Paul, Minnesota
One Form 483 · 2005 · 9 observations
Latest: Form 483, Sep 1, 2005 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2006-02-09 | 483 Form 483 | St. Paul, Minnesota | 1 | $99 |
| 2005-09-01 | 483 Form 483 | Saint Paul, Minnesota | 9 | $99 |
Investigators on these documents
Adisony Stone (1)Kimberly Lewandowski-Walker (1)Ralph W. Jerkdal (1)
FEI number 2124215 · most recent document Feb 9, 2006
About Guidant Corporation
How many FDA Form 483s has Guidant Corporation received?
FDA Intel has 2 Form 483s on file for Guidant Corporation; the most recent is dated Feb 9, 2006.
When was Guidant Corporation last inspected by FDA?
The most recent FDA inspection document on file for Guidant Corporation is a Form 483 dated Feb 9, 2006, for the site in St. Paul, Minnesota.
What did FDA cite at Guidant Corporation?
The regulations cited most in the observations on file for Guidant Corporation are 21 CFR 820.100 (Corrective and preventive action), 1 time; 21 CFR 820.184 (Device history record), 1 time; 21 CFR 820.40 (Document controls), 1 time.