University Of Michigan
FDA inspection history in Ann Arbor, Michigan, 2016 to 2018
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2016: one Form 483; 2017: one warning letter; 2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18Two Form 483s and one warning letter, at Ann Arbor, Michigan.
- 2016The longest 483 on file: 8 observations over 6 pages at Ann Arbor, Michigan.
Cited most
Across all University Of Michigan observations on file
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.28Personnel responsibilities2
- 21 CFR 211.167(a)Special testing requirements1
- 21 CFR 211.192Production record review1
The complete University Of Michigan file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Ann Arbor, Michigan
Two Form 483s and one warning letter · 2016 to 2018 · 13 observations
Latest: Form 483, Dec 3, 2018 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-12-03 | 483 Form 483 | Ann Arbor, Michigan | 5 | $99 |
| 2017-09-28 | Warning letter Warning letter | Ann Arbor, Michigan | — | $99 |
| 2016-06-29 | 483 Form 483 | Ann Arbor, Michigan | 8 | $99 |
Investigators on these documents
FEI number 3003531601 · most recent document Dec 3, 2018
About University Of Michigan
How many FDA Form 483s has University Of Michigan received?
FDA Intel has 2 Form 483s on file for University Of Michigan; the most recent is dated Dec 3, 2018.
When was University Of Michigan last inspected by FDA?
The most recent FDA inspection document on file for University Of Michigan is a Form 483 dated Dec 3, 2018, for the site in Ann Arbor, Michigan.
What did FDA cite at University Of Michigan?
The regulations cited most in the observations on file for University Of Michigan are 21 CFR 211.42 (Design and construction features), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.28 (Personnel responsibilities), 2 times.
Has University Of Michigan received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for University Of Michigan; the most recent is dated Sep 28, 2017.