Akorn, Inc.
Form 483 issued November 10, 2009 · Lake Forest, Illinois
- Inspection
- Oct 19 – Nov 10, 2009
- Investigator
- Debra I. Love
- Observations
- 2
- Pages
- 3
- FEI number
- 3003102962
In short: On November 10, 2009, FDA issued a Form 483 with 2 observations to Akorn, Inc. in Lake Forest, Illinois (FEI 3003102962) after an inspection that ran Oct 19 – Nov 10, 2009. The investigator was Debra I. Love. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198(a) (1×) · 211.198(b)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the handling of written and oral complaints related to drug products are…
- 02
Complaint records are deficient in that they do not include the…
This inspection in context
Debra I. Love
13 documents · 2009–2018
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 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Akorn, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Akorn, Inc.?
Debra I. Love is named on this Form 483, for the inspection of Oct 19 – Nov 10, 2009. Each investigator has a profile showing what they cite most.
When was Akorn, Inc. inspected by FDA?
The inspection ran Oct 19 – Nov 10, 2009, and the Form 483 is dated November 10, 2009.
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.