Akorn, Inc.
Form 483 issued May 19, 2011 · Somerset, New Jersey
- Inspection
- May 9 – May 19, 2011
- Investigator
- Paul L. Bellamy
- Observations
- 1
- Pages
- 2
- FEI number
- 2246848
In short: On May 19, 2011, FDA issued a Form 483 with 1 observation to Akorn, Inc. in Somerset, New Jersey (FEI 2246848) after an inspection that ran May 9 – May 19, 2011. The investigator was Paul L. Bellamy. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Paul L. Bellamy
4 documents · 2011–2016
Cites 211.113(b) (control of microbiological contamination) 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 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Akorn, Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Akorn, Inc.?
Paul L. Bellamy is named on this Form 483, for the inspection of May 9 – May 19, 2011. Each investigator has a profile showing what they cite most.
When was Akorn, Inc. inspected by FDA?
The inspection ran May 9 – May 19, 2011, and the Form 483 is dated May 19, 2011.
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.