Boston Scientific Corporation
FDA inspection history in Spencer, Indiana, 2005 to 2015
- 2
- Form 483s
Every document, by year
- Form 483
2005: one Form 483; 2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2005One Form 483, at Spencer, Indiana.
- 2005The longest 483 on file: 4 observations over 3 pages at Spencer, Indiana.
- 2015One Form 483, at Spencer, Indiana.
Cited most
Across all Boston Scientific observations on file
- 21 CFR 820.198Complaint files2
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.160Distribution1
- 21 CFR 820.70(c)Production and process controls1
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
Spencer, Indiana
Two Form 483s · 2005 to 2015 · 5 observations
Latest: Form 483, Jul 15, 2015 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-07-15 | 483 Form 483 | Spencer, Indiana | 1 | $99 |
| 2005-09-12 | 483 Form 483 | Spencer, Indiana | 4 | $99 |
Investigators on these documents
FEI number 1828132 · most recent document Jul 15, 2015
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 Jul 15, 2015.
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 Jul 15, 2015, for the site in Spencer, Indiana.
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), 2 times; 21 CFR 803.50 (If I am a manufacturer, what reporting requirements apply to me?), 1 time; 21 CFR 820.160 (Distribution), 1 time.