Advocate Lutheran General Hospital
FDA inspection history in Park Ridge, Illinois, 2016
- 1
- Form 483
Every document, by year
- Form 483
2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Park Ridge, Illinois.
Cited most
Across all Advocate Lutheran General Hospital observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?2
- 21 CFR 803.30(a)(1)If I am a user facility, what reporting requirements apply to me?2
- 21 CFR 803.11What form should I use to submit reports of individual adverse events and where do I obtain these forms?1
- 21 CFR 803.18(b)(1)(i)What are the requirements for establishing and maintaining MDR files or records that apply to me?1
- 21 CFR 803.32If I am a user facility, what information must I submit in my individual adverse event reports?1
The complete Advocate Lutheran General Hospital file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Park Ridge, Illinois
One Form 483 · 2016 · 7 observations
Latest: Form 483, Jan 11, 2016 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-01-11 | 483 Form 483 | Park Ridge, Illinois | 7 | $99 |
Investigators on these documents
FEI number 3005310193 · most recent document Jan 11, 2016
About Advocate Lutheran General Hospital
How many FDA Form 483s has Advocate Lutheran General Hospital received?
FDA Intel has 1 Form 483 on file for Advocate Lutheran General Hospital; the most recent is dated Jan 11, 2016.
When was Advocate Lutheran General Hospital last inspected by FDA?
The most recent FDA inspection document on file for Advocate Lutheran General Hospital is a Form 483 dated Jan 11, 2016, for the site in Park Ridge, Illinois.
What did FDA cite at Advocate Lutheran General Hospital?
The regulations cited most in the observations on file for Advocate Lutheran General Hospital are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 2 times; 21 CFR 803.30(a)(1) (If I am a user facility, what reporting requirements apply to me?), 2 times; 21 CFR 803.11 (What form should I use to submit reports of individual adverse events and where do I obtain these forms?), 1 time.