Boston Scientifc Scimed
FDA inspection history in Maple Grove, Minnesota, 2005
- 1
- Form 483
Every document, by year
- Form 483
2005: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2005One Form 483, at Maple Grove, Minnesota.
Cited most
Across all Boston Scientifc Scimed observations on file
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?2
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.198Complaint files1
- 21 CFR 820.80Receiving, in-process, and finished device acceptance1
The complete Boston Scientifc Scimed file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Maple Grove, Minnesota
One Form 483 · 2005 · 5 observations
Latest: Form 483, Aug 25, 2005 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2005-08-25 | 483 Form 483 | Maple Grove, Minnesota | 5 | $99 |
Investigators on these documents
Billi Jo M. Johnson (1)Hecelyn M. Muggli (1)Ralph W. Jerkdal (1)
FEI number 3002095335 · most recent document Aug 25, 2005
About Boston Scientifc Scimed
How many FDA Form 483s has Boston Scientifc Scimed received?
FDA Intel has 1 Form 483 on file for Boston Scientifc Scimed; the most recent is dated Aug 25, 2005.
When was Boston Scientifc Scimed last inspected by FDA?
The most recent FDA inspection document on file for Boston Scientifc Scimed is a Form 483 dated Aug 25, 2005, for the site in Maple Grove, Minnesota.
What did FDA cite at Boston Scientifc Scimed?
The regulations cited most in the observations on file for Boston Scientifc Scimed are 21 CFR 803.50 (If I am a manufacturer, what reporting requirements apply to me?), 2 times; 21 CFR 820.100 (Corrective and preventive action), 1 time; 21 CFR 820.198 (Complaint files), 1 time.