Akorn, Inc.
Form 483 issued June 30, 2009 · Decatur, Illinois
- Inspection
- Jun 1 – Jun 30, 2009
- Investigators
- Debra I. Love· Lequita M. Mayhew
- Observations
- 13
- Pages
- 22
- FEI number
- 1450114
In short: On June 30, 2009, FDA issued a Form 483 with 13 observations to Akorn, Inc. in Decatur, Illinois (FEI 1450114) after an inspection that ran Jun 1 – Jun 30, 2009. The investigators were Debra I. Love and Lequita M. Mayhew. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 8 of 13 observations.
Most cited: 21 CFR 211.192 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and…
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 9 documents on file for this site, in date order, with what was cited at each inspection.
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 13 observations on this Form 483, mostly about quality system, facilities & equipment and production. 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.?
Debra I. Love and Lequita M. Mayhew are named on this Form 483, for the inspection of Jun 1 – Jun 30, 2009. Each investigator has a profile showing what they cite most.
When was Akorn, Inc. inspected by FDA?
The inspection ran Jun 1 – Jun 30, 2009, and the Form 483 is dated June 30, 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.