Innovative Surgical Solutions, LLC
FDA inspection history in Wixom, Michigan, 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 Wixom, Michigan.
Cited most
Across all Innovative Surgical Solutions observations on file
- 21 CFR 806.20(b)(4)Records of corrections and removals not required to be reported1
- 21 CFR 820.30(e)Design controls1
The complete Innovative Surgical Solutions file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Wixom, Michigan
One Form 483 · 2015 · 2 observations
Latest: Form 483, May 20, 2015 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-05-20 | 483 Form 483 | Wixom, Michigan | 2 | $99 |
Investigators on these documents
FEI number 3009274855 · most recent document May 20, 2015
About Innovative Surgical Solutions, LLC
How many FDA Form 483s has Innovative Surgical Solutions, LLC received?
FDA Intel has 1 Form 483 on file for Innovative Surgical Solutions, LLC; the most recent is dated May 20, 2015.
When was Innovative Surgical Solutions, LLC last inspected by FDA?
The most recent FDA inspection document on file for Innovative Surgical Solutions, LLC is a Form 483 dated May 20, 2015, for the site in Wixom, Michigan.
What did FDA cite at Innovative Surgical Solutions, LLC?
The regulations cited most in the observations on file for Innovative Surgical Solutions, LLC are 21 CFR 806.20(b)(4) (Records of corrections and removals not required to be reported), 1 time; 21 CFR 820.30(e) (Design controls), 1 time.