Boston Scientifc Scimed
Form 483 issued August 25, 2005 · Maple Grove, Minnesota
- Inspection
- Jul 22 – Aug 25, 2005
- Investigators
- Billi Jo M. Johnson· Hecelyn M. Muggli· Ralph W. Jerkdal
- Observations
- 5
- Pages
- 3
- FEI number
- 3002095335
In short: On August 25, 2005, FDA issued a Form 483 with 5 observations to Boston Scientifc Scimed in Maple Grove, Minnesota (FEI 3002095335) after an inspection that ran Jul 22 – Aug 25, 2005. The investigators were Billi Jo M. Johnson, Hecelyn M. Muggli and Ralph W. Jerkdal. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
4 of 5 observations on this 483 concern capa.
Most cited: 21 CFR 803.50 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 03
Complaints representing events that are MDR reportable were not promptly reviewed, evaluated, and investigated…
- 04
The procedures for implementing corrective and preventive…
This inspection in context
Billi Jo M. Johnson
1 document · 2005
Cites 803.50 (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in Minnesota.
The firmBoston Scientifc Scimed history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Boston Scientifc Scimed?
FDA listed 5 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Boston Scientifc Scimed?
Billi Jo M. Johnson, Hecelyn M. Muggli and Ralph W. Jerkdal are named on this Form 483, for the inspection of Jul 22 – Aug 25, 2005. Each investigator has a profile showing what they cite most.
When was Boston Scientifc Scimed inspected by FDA?
The inspection ran Jul 22 – Aug 25, 2005, and the Form 483 is dated August 25, 2005.
How do I get the full Form 483 for Boston Scientifc Scimed?
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.