American Medical Systems Innovation
FDA inspection history in San Jose, California, 2015
- 1
- Form 483
Every document, by year
- Form 483
2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at San Jose, California.
Cited most
Across all American Medical Systems Innovation observations on file
- 21 CFR 803.56If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?1
- 21 CFR 820.30(g)Design controls1
The complete American Medical Systems Innovation file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
San Jose, California
One Form 483 · 2015 · 2 observations
Latest: Form 483, Apr 3, 2015 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-04-03 | 483 Form 483 | San Jose, California | 2 | $99 |
Investigators on these documents
FEI number 2937094 · most recent document Apr 3, 2015
About American Medical Systems Innovation
How many FDA Form 483s has American Medical Systems Innovation received?
FDA Intel has 1 Form 483 on file for American Medical Systems Innovation; the most recent is dated Apr 3, 2015.
When was American Medical Systems Innovation last inspected by FDA?
The most recent FDA inspection document on file for American Medical Systems Innovation is a Form 483 dated Apr 3, 2015, for the site in San Jose, California.
What did FDA cite at American Medical Systems Innovation?
The regulations cited most in the observations on file for American Medical Systems Innovation are 21 CFR 803.56 (If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?), 1 time; 21 CFR 820.30(g) (Design controls), 1 time.