Akorn, Inc.
Form 483 issued June 10, 2016 · Decatur, Illinois
- Inspection
- Jun 1 – Jun 10, 2016
- Investigators
- Anastasia M. Shields· Patric C. Klotzbuecher· Samina S. Khan
- Observations
- 6
- Pages
- 7
- FEI number
- 1450114
In short: On June 10, 2016, FDA issued a Form 483 with 6 observations to Akorn, Inc. in Decatur, Illinois (FEI 1450114) after an inspection that ran Jun 1 – Jun 10, 2016. The investigators were Anastasia M. Shields, Patric C. Klotzbuecher and Samina S. Khan. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Production and quality system account for 4 of 6 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations from written production and process control procedures are…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Investigations of a failure of a batch or any of its components to meet any of…
- 04
Quality controls do not include a determination of conformance to written descriptions of sampling…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Akorn, Inc.?
FDA listed 6 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Akorn, Inc.?
Anastasia M. Shields, Patric C. Klotzbuecher and Samina S. Khan are named on this Form 483, for the inspection of Jun 1 – Jun 10, 2016. Each investigator has a profile showing what they cite most.
When was Akorn, Inc. inspected by FDA?
The inspection ran Jun 1 – Jun 10, 2016, and the Form 483 is dated June 10, 2016.
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.