Akorn, Inc.
Form 483 issued April 4, 2016 · Somerset, New Jersey
- Inspection
- Apr 4, 2016
- Investigators
- Adetutu Gidado· Barbara J. Wilimczyk-Macri· Nancy M. Espinal
- Observations
- 12
- Pages
- 4
- FEI number
- 2246848
In short: On April 4, 2016, FDA issued a Form 483 with 12 observations to Akorn, Inc. in Somerset, New Jersey (FEI 2246848) after an inspection that ran Apr 4, 2016. The investigators were Adetutu Gidado, Barbara J. Wilimczyk-Macri and Nancy M. Espinal. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and production account for 10 of 12 observations.
Most cited: 21 CFR 211.194 (4×) · 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Written investigations are not thorough, do not include. appropriate corrective actions, and do not include documentation…
- 03
Stability testing program does not require complete testing in…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Adetutu Gidado
16 documents · 2016–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) 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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Akorn, Inc.?
FDA listed 12 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Akorn, Inc.?
Adetutu Gidado, Barbara J. Wilimczyk-Macri and Nancy M. Espinal are named on this Form 483, for the inspection of Apr 4, 2016. Each investigator has a profile showing what they cite most.
When was Akorn, Inc. inspected by FDA?
The inspection ran Apr 4, 2016, and the Form 483 is dated April 4, 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.