Indiana University Hospital

FDA inspection history in Indianapolis, Indiana, 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.

  1. 2016One Form 483, at Indianapolis, Indiana.

Cited most

Across all Indiana University Hospital observations on file

  • 21 CFR 803.17
    What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
    1
  • 21 CFR 803.18
    What are the requirements for establishing and maintaining MDR files or records that apply to me?
    1

The complete Indiana University Hospital file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2016-02-03483 Form 483$99

Investigators on these documents

Joseph R. Strelnik (1)

FEI number 3004492321 · most recent document Feb 3, 2016

About Indiana University Hospital

How many FDA Form 483s has Indiana University Hospital received?

FDA Intel has 1 Form 483 on file for Indiana University Hospital; the most recent is dated Feb 3, 2016.

When was Indiana University Hospital last inspected by FDA?

The most recent FDA inspection document on file for Indiana University Hospital is a Form 483 dated Feb 3, 2016, for the site in Indianapolis, Indiana.

What did FDA cite at Indiana University Hospital?

The regulations cited most in the observations on file for Indiana University Hospital are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 803.18 (What are the requirements for establishing and maintaining MDR files or records that apply to me?), 1 time.