International Medsurg Connection, Inc.
Form 483 issued November 22, 2017 · Schaumburg, Illinois
- Inspection
- Oct 25 – Nov 22, 2017
- Investigator
- Amanda Dinaro
- Observations
- 4
- Pages
- 5
- FEI number
- 3000210101
In short: On November 22, 2017, FDA issued a Form 483 with 4 observations to International Medsurg Connection, Inc. in Schaumburg, Illinois (FEI 3000210101) after an inspection that ran Oct 25 – Nov 22, 2017. The investigator was Amanda Dinaro. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
3 of 4 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Complaints involving the possible failure of a device to meet any of its specifications were…
- 03
Procedures to ensure sampling methods are adequate for their intended use have…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Amanda Dinaro
7 documents · 2017–2023
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Illinois.
The firmInternational Medsurg Connection, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at International Medsurg Connection, Inc.?
FDA listed 4 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected International Medsurg Connection, Inc.?
Amanda Dinaro is named on this Form 483, for the inspection of Oct 25 – Nov 22, 2017. Each investigator has a profile showing what they cite most.
When was International Medsurg Connection, Inc. inspected by FDA?
The inspection ran Oct 25 – Nov 22, 2017, and the Form 483 is dated November 22, 2017.
How do I get the full Form 483 for International Medsurg Connection, Inc.?
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.