Medaus, Inc.
FDA inspection history in Birmingham, Alabama, 2013 to 2018
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2013: one Form 483; 2014: one warning letter; 2016: one fda_correspondence and one Form 483; 2018: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–18Two Form 483s, one warning letter, one fda_correspondence and one close-out letter, at Birmingham, Alabama.
- 2013The longest 483 on file: 12 observations over 6 pages at Birmingham, Alabama.
Cited most
Across all Medaus observations on file
- 21 CFR 211.42Design and construction features7
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.111Time limitations on production2
- 21 CFR 211.142Warehousing procedures2
- 21 CFR 211.166Stability testing2
The complete Medaus file.
All 4 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
Birmingham, Alabama
Two Form 483s, one close-out letter, one fda_correspondence and one warning letter · 2013 to 2018 · 21 observations
Latest: Close-out, Mar 8, 2018 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-03-08 | Close-out Close-out letter | Birmingham, Alabama | — | $99 |
| 2016-05-03 | fda_correspondence FDA document | Birmingham, Alabama | — | — |
| 2016-03-11 | 483 Form 483 | Birmingham, Alabama | 9 | $99 |
| 2014-01-15 | Warning letter Warning letter | Birmingham, Alabama | — | $99 |
| 2013-03-22 | 483 Form 483 | Birmingham, Alabama | 12 | $99 |
Investigators on these documents
Bruce H. McCullough (1)Claire M. Minden (1)Jennifer Del Valle (1)Meisha R. Waters (1)
FEI number 3001298034 · most recent document Mar 8, 2018
About Medaus, Inc.
How many FDA Form 483s has Medaus, Inc. received?
FDA Intel has 2 Form 483s on file for Medaus, Inc.; the most recent is dated Mar 11, 2016.
When was Medaus, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Medaus, Inc. is a Form 483 dated Mar 11, 2016, for the site in Birmingham, Alabama.
What did FDA cite at Medaus, Inc.?
The regulations cited most in the observations on file for Medaus, Inc. are 21 CFR 211.42 (Design and construction features), 7 times; 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.111 (Time limitations on production), 2 times.
Has Medaus, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Medaus, Inc.; the most recent is dated Jan 15, 2014.