Boston Scientific Corporation
FDA inspection history in Fremont, California, 2017
- 1
- Form 483
Every document, by year
- Form 483
2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Fremont, California.
Cited most
Across all Boston Scientific observations on file
- 21 CFR 806.10(a)(1)Reports of corrections and removals1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(c)Complaint files1
The complete Boston Scientific file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Fremont, California
One Form 483 · 2017 · 3 observations
Latest: Form 483, Jan 11, 2017 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-01-11 | 483 Form 483 | Fremont, California | 3 | $99 |
Investigators on these documents
FEI number 2939204 · most recent document Jan 11, 2017
About Boston Scientific Corporation
How many FDA Form 483s has Boston Scientific Corporation received?
FDA Intel has 1 Form 483 on file for Boston Scientific Corporation; the most recent is dated Jan 11, 2017.
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 Jan 11, 2017, for the site in Fremont, California.
What did FDA cite at Boston Scientific Corporation?
The regulations cited most in the observations on file for Boston Scientific Corporation are 21 CFR 806.10(a)(1) (Reports of corrections and removals), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.198(c) (Complaint files), 1 time.