Summit Medical, LLC
FDA inspection history in Eagan, Minnesota, 2018
- 1
- Form 483
Every document, by year
- Form 483
2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Eagan, Minnesota.
Cited most
Across all Summit Medical observations on file
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.75(a)Process validation1
- 21 CFR 820.80(b)Receiving, in-process, and finished device acceptance1
The complete Summit Medical file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Eagan, Minnesota
One Form 483 · 2018 · 3 observations
Latest: Form 483, Mar 9, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-03-09 | 483 Form 483 | Eagan, Minnesota | 3 | $99 |
Investigators on these documents
FEI number 3008719017 · most recent document Mar 9, 2018
About Summit Medical, LLC
How many FDA Form 483s has Summit Medical, LLC received?
FDA Intel has 1 Form 483 on file for Summit Medical, LLC; the most recent is dated Mar 9, 2018.
When was Summit Medical, LLC last inspected by FDA?
The most recent FDA inspection document on file for Summit Medical, LLC is a Form 483 dated Mar 9, 2018, for the site in Eagan, Minnesota.
What did FDA cite at Summit Medical, LLC?
The regulations cited most in the observations on file for Summit Medical, LLC are 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.75(a) (Process validation), 1 time; 21 CFR 820.80(b) (Receiving, in-process, and finished device acceptance), 1 time.