Akorn, Inc.
Form 483 issued May 17, 2022 · Somerset, New Jersey
- Inspection
- Apr 18 – May 17, 2022
- Investigators
- Guerlain Ulysse· Ko U. Min· Mindy M. Chou
- Observations
- 9
- Pages
- 19
- FEI number
- 2246848
In short: On May 17, 2022, FDA issued a Form 483 with 9 observations to Akorn, Inc. in Somerset, New Jersey (FEI 2246848) after an inspection that ran Apr 18 – May 17, 2022. The investigators were Guerlain Ulysse, Ko U. Min, Mindy M. Chou and Nicholas Violand. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 02
Investigations ofan unexplained discrepancy and a failure of a batch or any of its components to…
- 03
The quality control unit lacks the responsibility and authority to approve and…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAkorn, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 314.81(b)(1)(ii)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Akorn, Inc.?
FDA listed 9 observations on this Form 483, mostly about quality system, laboratory controls and production. 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.?
Guerlain Ulysse, Ko U. Min, Mindy M. Chou and Nicholas Violand are named on this Form 483, for the inspection of Apr 18 – May 17, 2022. Each investigator has a profile showing what they cite most.
When was Akorn, Inc. inspected by FDA?
The inspection ran Apr 18 – May 17, 2022, and the Form 483 is dated May 17, 2022.
How do I get the full Form 483 for Akorn, Inc.?
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