Akorn, Inc.
Form 483 issued September 17, 2010 · Decatur, Illinois
- Inspection
- Aug 25 – Sep 17, 2010
- Investigators
- Carl A. Huffman Iii· Phung Thien Nguyen
- Observations
- 8
- Pages
- 8
- FEI number
- 1450114
In short: On September 17, 2010, FDA issued a Form 483 with 8 observations to Akorn, Inc. in Decatur, Illinois (FEI 1450114) after an inspection that ran Aug 25 – Sep 17, 2010. The investigators were Carl A. Huffman Iii and Phung Thien Nguyen. Most observations concern materials and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Materials and production account for 5 of 8 observations.
Most cited: 21 CFR 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug products failing to meet established standards, specifications, and quality control…
- 02
Failure to reject any lot of components that did not meet the appropriate written specifications for…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 04
Each lot of components, drug product containers, and closures is not withheld from usc until the…
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
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Akorn, Inc.?
FDA listed 8 observations on this Form 483, mostly about materials, production and laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). 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 Aug 25 – Sep 17, 2010. Each investigator has a profile showing what they cite most.
When was Akorn, Inc. inspected by FDA?
The inspection ran Aug 25 – Sep 17, 2010, and the Form 483 is dated September 17, 2010.
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.