Akorn, Inc.
Form 483 issued September 17, 2020 · Decatur, Illinois
- Inspection
- Sep 7, 2010 – Sep 17, 2020
- Investigators
- Carl A. Huffman Iii· Phung Thien Nguyen
- Observations
- 1
- Pages
- 2
- FEI number
- 1419498
In short: On September 17, 2020, FDA issued a Form 483 with 1 observation to Akorn, Inc. in Decatur, Illinois (FEI 1419498) after an inspection that ran Sep 7, 2010 – Sep 17, 2020. The investigators were Carl A. Huffman Iii and Phung Thien Nguyen. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug product production and control records, are not reviewed by the quality control unit to determine…
This inspection in context
Carl A. Huffman Iii
3 documents · 2010–2023
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in Illinois.
The firmAkorn, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Akorn, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Akorn, Inc.?
Carl A. Huffman Iii and Phung Thien Nguyen are named on this Form 483, for the inspection of Sep 7, 2010 – Sep 17, 2020. Each investigator has a profile showing what they cite most.
When was Akorn, Inc. inspected by FDA?
The inspection ran Sep 7, 2010 – Sep 17, 2020, and the Form 483 is dated September 17, 2020.
How do I get the full Form 483 for Akorn, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.