Exercore, LLC
Form 483 issued December 18, 2018 · Shakopee, Minnesota
- Inspection
- Nov 19 – Dec 18, 2018
- Investigator
- Jennifer S. Ness
- Observations
- 6
- Pages
- 5
- FEI number
- 3011704250
In short: On December 18, 2018, FDA issued a Form 483 with 6 observations to Exercore, LLC in Shakopee, Minnesota (FEI 3011704250) after an inspection that ran Nov 19 – Dec 18, 2018. The investigator was Jennifer S. Ness. Most observations concern cAPA and design controls.
At a glance
4 of 6 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 02
Procedures for corrective and preventive action have…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 04
Written MDR procedures have not…
This inspection in context
Jennifer S. Ness
5 documents · 2015–2019
Cites 820.90 (nonconforming product) more than any other section. Most of their documents are for sites in Wisconsin.
The firmExercore, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Exercore, LLC?
FDA listed 6 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The opening words of each observation are shown on this page.
Who inspected Exercore, LLC?
Jennifer S. Ness is named on this Form 483, for the inspection of Nov 19 – Dec 18, 2018. Each investigator has a profile showing what they cite most.
When was Exercore, LLC inspected by FDA?
The inspection ran Nov 19 – Dec 18, 2018, and the Form 483 is dated December 18, 2018.
How do I get the full Form 483 for Exercore, 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.