Advocate Lutheran General Hospital
Form 483 issued January 11, 2016 · Park Ridge, Illinois
- Inspection
- Dec 3, 2015 – Jan 11, 2016
- Investigator
- Brittani N. Franklin
- Observations
- 7
- Pages
- 5
- FEI number
- 3005310193
In short: On January 11, 2016, FDA issued a Form 483 with 7 observations to Advocate Lutheran General Hospital in Park Ridge, Illinois (FEI 3005310193) after an inspection that ran Dec 3, 2015 – Jan 11, 2016. The investigator was Brittani N. Franklin. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.30 (if I am a user facility, what reporting requirements apply to me?).
At a glance
7 of 7 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
The user facility did not submit FDA Form 3500A or eleclmnic equivalent to FDA and the…
- 02
The user facility did not submit FDA Form 3500A or electronic equivalent to the known device…
- 0321 CFR 803.11
Observation 3: scanned text, readable in the full document.
- 04
MDR event files do not contain or reference all adverse event information in the possession of…
This inspection in context
Brittani N. Franklin
5 documents · 2016–2019
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in Illinois.
The firmAdvocate Lutheran General Hospital history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.30(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advocate Lutheran General Hospital?
FDA listed 7 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.30 (if I am a user facility, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Advocate Lutheran General Hospital?
Brittani N. Franklin is named on this Form 483, for the inspection of Dec 3, 2015 – Jan 11, 2016. Each investigator has a profile showing what they cite most.
When was Advocate Lutheran General Hospital inspected by FDA?
The inspection ran Dec 3, 2015 – Jan 11, 2016, and the Form 483 is dated January 11, 2016.
How do I get the full Form 483 for Advocate Lutheran General Hospital?
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.