Overview
- 7 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-03-05.
At a glance
Inspections
7
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Feb 2019 – 5 Mar 2019 | Human Drugs | Clean | |
| 21 Feb 2019 – 28 Feb 2019 | Human Drugs | Clean | |
| 20 Mar 2017 | Human Drugs | Clean | |
| 18 Aug 2015 – 18 Dec 2015 | Human Drugs | Clean | |
| 10 Nov 2009 | Not recorded | 483 | View 483 → |
| 10 Oct 2006 | Not recorded | Clean | |
| 17 Jan 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Akorn, Inc.'s 1 Form 483
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat