Akorn, Inc.
FDA inspection history in Lake Forest, Illinois, 2009 to 2012
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2009: one Form 483; 2012: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One Form 483, at Lake Forest, Illinois.
- 2012One warning letter, at Lake Forest, Illinois.
Cited most
Across all Akorn observations on file
- 21 CFR 211.198(a)Complaint files2
The complete Akorn file.
All 2 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
Lake Forest, Illinois
One warning letter and one Form 483 · 2009 to 2012 · 2 observations
Latest: Warning letter, Oct 2, 2012 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2012-10-02 | Warning letter Warning letter | Lake Forest, Illinois | — | $99 |
| 2009-11-10 | 483 Form 483 | Lake Forest, Illinois | 2 | $99 |
Investigators on these documents
FEI number 3003102962 · most recent document Oct 2, 2012
About Akorn, Inc.
How many FDA Form 483s has Akorn, Inc. received?
FDA Intel has 1 Form 483 on file for Akorn, Inc.; the most recent is dated Nov 10, 2009.
When was Akorn, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Akorn, Inc. is a Form 483 dated Nov 10, 2009, for the site in Lake Forest, Illinois.
What did FDA cite at Akorn, Inc.?
The regulations cited most in the observations on file for Akorn, Inc. are 21 CFR 211.198(a) (Complaint files), 2 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 Oct 2, 2012.