Guidant Corporation
Form 483 issued February 9, 2006 · St. Paul, Minnesota
- Inspection
- Dec 15, 2005 – Feb 9, 2006
- Investigators
- Adisony Stone· Ralph W. Jerkdal
- Observations
- 1
- Pages
- 1
- FEI number
- 2124215
In short: On February 9, 2006, FDA issued a Form 483 with 1 observation to Guidant Corporation in St. Paul, Minnesota (FEI 2124215) after an inspection that ran Dec 15, 2005 – Feb 9, 2006. The investigators were Adisony Stone and Ralph W. Jerkdal. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Not all of the actions needed to correct and prevent the recurrence of f nonconforming product…
This inspection in context
Adisony Stone
1 document · 2006
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Minnesota.
The firmGuidant Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Guidant Corporation?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Guidant Corporation?
Adisony Stone and Ralph W. Jerkdal are named on this Form 483, for the inspection of Dec 15, 2005 – Feb 9, 2006. Each investigator has a profile showing what they cite most.
When was Guidant Corporation inspected by FDA?
The inspection ran Dec 15, 2005 – Feb 9, 2006, and the Form 483 is dated February 9, 2006.
How do I get the full Form 483 for Guidant Corporation?
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.