Guidant Corporation
Form 483 issued September 1, 2005 · Saint Paul, Minnesota
- Inspection
- Sep 1, 2005
- Investigator
- Kimberly Lewandowski-Walker
- Observations
- 9
- Pages
- 7
- FEI number
- 2124215
In short: On September 1, 2005, FDA issued a Form 483 with 9 observations to Guidant Corporation in Saint Paul, Minnesota (FEI 2124215) after an inspection that ran Sep 1, 2005. The investigator was Kimberly Lewandowski-Walker. Most observations concern records & documents; the most-cited regulation is 21 CFR 820.40 (document controls).
At a glance
1 of 1 observations on this 483 concern records & documents.
Most cited: 21 CFR 820.40 (1×) · 820.184 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Kimberly Lewandowski-Walker
5 documents · 2005–2017
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Florida.
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 820.40
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Guidant Corporation?
FDA listed 9 observations on this Form 483, mostly about records & documents. The most-cited regulation is 21 CFR 820.40 (document controls). The opening words of each observation are shown on this page.
Who inspected Guidant Corporation?
Kimberly Lewandowski-Walker is named on this Form 483, for the inspection of Sep 1, 2005. Each investigator has a profile showing what they cite most.
When was Guidant Corporation inspected by FDA?
The inspection ran Sep 1, 2005, and the Form 483 is dated September 1, 2005.
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.