Akorn, Inc.
Form 483 issued August 30, 2018 · Somerset, New Jersey
- Inspection
- Jul 23 – Aug 30, 2018
- Investigators
- Atul J. Agrawal· Guerlain Ulysse· Ko U. Min
- Observations
- 11
- Pages
- 22
- FEI number
- 2246848
In short: On August 30, 2018, FDA issued a Form 483 with 11 observations to Akorn, Inc. in Somerset, New Jersey (FEI 2246848) after an inspection that ran Jul 23 – Aug 30, 2018. The investigators were Atul J. Agrawal, Guerlain Ulysse, Ko U. Min and Tamil Arasu. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Laboratory controls and quality system account for 7 of 11 observations.
Most cited: 21 CFR 211.192 (2×) · 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
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 03
The responsibilities and procedmes applicable to the quality control unit are not in…
- 04
The written stability testing…
This inspection in context
Atul J. Agrawal
5 documents · 2011–2018
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Akorn, Inc.?
FDA listed 11 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. 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.?
Atul J. Agrawal, Guerlain Ulysse, Ko U. Min and Tamil Arasu are named on this Form 483, for the inspection of Jul 23 – Aug 30, 2018. Each investigator has a profile showing what they cite most.
When was Akorn, Inc. inspected by FDA?
The inspection ran Jul 23 – Aug 30, 2018, and the Form 483 is dated August 30, 2018.
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.