Akorn, Inc.
FDA inspection history across 2 sites, 2009 to 2019
- 6
- Form 483s
- 2
- Close-outs
- 1
- Warning letter
Every document, by year
- Close-out
- Warning letter
- Form 483
2009: one Form 483; 2010: one Form 483; 2016: one Form 483; 2017: one Form 483; 2018: two Form 483s; 2019: two close-out letters and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2009–10Two Form 483s, at Decatur, Illinois.
- 2016–19Four Form 483s, two close-out letters and one warning letter, at Decatur, Illinois and Lake Forest, Illinois.
- 2018The longest 483 on file: 13 observations over 24 pages at Decatur, Illinois.
Cited most
Across all Akorn observations on file
- 21 CFR 211.192Production record review6
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 314.81Other postmarketing reports4
- 21 CFR 211.100Written procedures; deviations3
The complete Akorn file.
All 9 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Decatur, Illinois
Six Form 483s and one warning letter · 2009 to 2019 · 56 observations
Latest: Warning letter, Jan 4, 2019 →Lake Forest, Illinois
Two close-out letters · 2019
Latest: Close-out, Jun 13, 2019 →
Documents
9 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-06-13 | Close-out Close-out letter | Lake Forest, Illinois | — | $99 |
| 2019-02-04 | Close-out Close-out letter | Lake Forest, Illinois | — | $99 |
| 2019-01-04 | Warning letter Warning letter | Decatur, Illinois | — | $99 |
| 2018-05-16 | 483 Form 483 | Decatur, Illinois | 13 | $99 |
| 2018-05-03 | 483 Form 483 | Decatur, Illinois | 13 | $99 |
| 2017-04-26 | 483 Form 483 | Decatur, Illinois | 3 | $99 |
| 2016-06-10 | 483 Form 483 | Decatur, Illinois | 6 | $99 |
| 2010-09-17 | 483 Form 483 | Decatur, Illinois | 8 | $99 |
| 2009-06-30 | 483 Form 483 | Decatur, Illinois | 13 | $99 |
Investigators on these documents
Sandra A. Hughes (2)Michele L. Glendenning (2)Michele Perry Williams (2)Debra I. Love (1)Lequita M. Mayhew (1)Samina S. Khan (1)Anastasia M. Shields (1)Patric C. Klotzbuecher (1)Phung Thien Nguyen (1)Brian D. Nicholson (1)Carl A. Huffman Iii (1)
FEI number 1450114 · most recent document Jun 13, 2019
About Akorn, Inc.
How many FDA Form 483s has Akorn, Inc. received?
FDA Intel has 6 Form 483s on file for Akorn, Inc.; the most recent is dated May 16, 2018.
When was Akorn, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Akorn, Inc. is a Form 483 dated May 16, 2018, for the site in Decatur, Illinois.
What did FDA cite at Akorn, Inc.?
The regulations cited most in the observations on file for Akorn, Inc. are 21 CFR 211.192 (Production record review), 6 times; 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times.
Has Akorn, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Akorn, Inc.; the most recent is dated Jan 4, 2019.