Boston Scientific Corporation
FDA inspection history across 2 sites, 2005
- 2
- Form 483s
Every document, by year
- Form 483
2005: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2005Two Form 483s, at Natick, Massachusetts and Stoneham, Massachusetts.
- 2005The longest 483 on file: 7 observations over 6 pages at Natick, Massachusetts.
Cited most
Across all Boston Scientific observations on file
- 21 CFR 820.198Complaint files3
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?2
- 21 CFR 820.20Management responsibility2
- 21 CFR 806.10Reports of corrections and removals1
The complete Boston Scientific 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
Natick, Massachusetts
One Form 483 · 2005 · 7 observations
Latest: Form 483, Aug 26, 2005 →Stoneham, Massachusetts
One Form 483 · 2005 · 3 observations
Latest: Form 483, Aug 26, 2005 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2005-08-26 | 483 Form 483 | Natick, Massachusetts | 7 | $99 |
| 2005-08-26 | 483 Form 483 | Stoneham, Massachusetts | 3 | $99 |
Investigators on these documents
FEI number 3000204642 · most recent document Aug 26, 2005
About Boston Scientific Corporation
How many FDA Form 483s has Boston Scientific Corporation received?
FDA Intel has 2 Form 483s on file for Boston Scientific Corporation; the most recent is dated Aug 26, 2005.
When was Boston Scientific Corporation last inspected by FDA?
The most recent FDA inspection document on file for Boston Scientific Corporation is a Form 483 dated Aug 26, 2005, for the site in Natick, Massachusetts.
What did FDA cite at Boston Scientific Corporation?
The regulations cited most in the observations on file for Boston Scientific Corporation are 21 CFR 820.198 (Complaint files), 3 times; 21 CFR 803.50 (If I am a manufacturer, what reporting requirements apply to me?), 2 times; 21 CFR 820.20 (Management responsibility), 2 times.