Boston Scientifc Corporation
FDA inspection history in Watertown, Massachusetts, 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 Watertown, Massachusetts.
Cited most
Across all Boston Scientifc observations on file
- 21 CFR 820.75Process validation2
- 21 CFR 820.90Nonconforming product2
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.184Device history record1
- 21 CFR 820.20Management responsibility1
The complete Boston Scientifc file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Watertown, Massachusetts
One Form 483 · 2005 · 9 observations
Latest: Form 483, Apr 7, 2005 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2005-04-07 | 483 Form 483 | Watertown, Massachusetts | 9 | $99 |
Investigators on these documents
FEI number 1219544 · most recent document Apr 7, 2005
About Boston Scientifc Corporation
How many FDA Form 483s has Boston Scientifc Corporation received?
FDA Intel has 1 Form 483 on file for Boston Scientifc Corporation; the most recent is dated Apr 7, 2005.
When was Boston Scientifc Corporation last inspected by FDA?
The most recent FDA inspection document on file for Boston Scientifc Corporation is a Form 483 dated Apr 7, 2005, for the site in Watertown, Massachusetts.
What did FDA cite at Boston Scientifc Corporation?
The regulations cited most in the observations on file for Boston Scientifc Corporation are 21 CFR 820.75 (Process validation), 2 times; 21 CFR 820.90 (Nonconforming product), 2 times; 21 CFR 820.100 (Corrective and preventive action), 1 time.