Summit Medical, LLC
Form 483 issued March 9, 2018 · Eagan, Minnesota
- Inspection
- Feb 27 – Mar 9, 2018
- Investigator
- Benjamin W. Anderson
- Observations
- 3
- Pages
- 4
- FEI number
- 3008719017
In short: On March 9, 2018, FDA issued a Form 483 with 3 observations to Summit Medical, LLC in Eagan, Minnesota (FEI 3008719017) after an inspection that ran Feb 27 – Mar 9, 2018. The investigator was Benjamin W. Anderson. Most observations concern production & process controls and cAPA.
At a glance
2 of 3 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for corrective and preventive action have…
- 03
Procedures for acceptance of incoming product…
This inspection in context
Benjamin W. Anderson
3 documents · 2018–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Minnesota.
The firmSummit Medical, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Summit Medical, LLC?
FDA listed 3 observations on this Form 483, mostly about production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Summit Medical, LLC?
Benjamin W. Anderson is named on this Form 483, for the inspection of Feb 27 – Mar 9, 2018. Each investigator has a profile showing what they cite most.
When was Summit Medical, LLC inspected by FDA?
The inspection ran Feb 27 – Mar 9, 2018, and the Form 483 is dated March 9, 2018.
How do I get the full Form 483 for Summit Medical, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.