Akorn, Inc.
Form 483 issued April 26, 2017 · Decatur, Illinois
- Inspection
- Apr 20 – Apr 26, 2017
- Investigator
- Brian D. Nicholson
- Observations
- 3
- Pages
- 4
- FEI number
- 1450114
In short: On April 26, 2017, FDA issued a Form 483 with 3 observations to Akorn, Inc. in Decatur, Illinois (FEI 1450114) after an inspection that ran Apr 20 – Apr 26, 2017. The investigator was Brian D. Nicholson. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) 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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Akorn, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Akorn, Inc.?
Brian D. Nicholson is named on this Form 483, for the inspection of Apr 20 – Apr 26, 2017. Each investigator has a profile showing what they cite most.
When was Akorn, Inc. inspected by FDA?
The inspection ran Apr 20 – Apr 26, 2017, and the Form 483 is dated April 26, 2017.
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.