Akorn, Inc.
FDA inspection history in Somerset, New Jersey, 2011 to 2022
- 4
- Form 483s
Every document, by year
- Form 483
2011: one Form 483; 2016: one Form 483; 2018: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One Form 483, at Somerset, New Jersey.
- 2016–18Two Form 483s, at Somerset, New Jersey.
- 2016The longest 483 on file: 12 observations over 4 pages at Somerset, New Jersey.
- 2022One Form 483, at Somerset, New Jersey.
Cited most
Across all Akorn observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.192Production record review5
- 21 CFR 211.194Laboratory records5
- 21 CFR 211.160General requirements4
- 21 CFR 211.166Stability testing3
The complete Akorn 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
Somerset, New Jersey
Four Form 483s · 2011 to 2022 · 24 observations
Latest: Form 483, May 17, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-05-17 | 483 Form 483 | Somerset, New Jersey | — | $99 |
| 2018-08-30 | 483 Form 483 | Somerset, New Jersey | 11 | $99 |
| 2016-04-04 | 483 Form 483 | Somerset, New Jersey | 12 | $99 |
| 2011-05-19 | 483 Form 483 | Somerset, New Jersey | 1 | $99 |
Investigators on these documents
Ko U. Min (2)Guerlain Ulysse (2)Barbara J. Wilimczyk-Macri (1)Mindy M. Chou (1)Nancy M. Espinal (1)Nicholas Violand (1)Paul L. Bellamy (1)Adetutu Gidado (1)Tamil Arasu (1)Atul J. Agrawal (1)
FEI number 2246848 · most recent document May 17, 2022
About Akorn, Inc.
How many FDA Form 483s has Akorn, Inc. received?
FDA Intel has 4 Form 483s on file for Akorn, Inc.; the most recent is dated May 17, 2022.
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 17, 2022, for the site in Somerset, New Jersey.
What did FDA cite at Akorn, Inc.?
The regulations cited most in the observations on file for Akorn, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.194 (Laboratory records), 5 times.