Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-08-02.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Jul 2019 – 2 Aug 2019 | Human Drugs | Clean | |
| 19 Aug 2014 – 9 Sep 2014 | Human Drugs | 483 | View 483 → |
| 18 Sep 2013 – 29 Oct 2013 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Sep 2014
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Liatte Krueger, Namita Kothary
9 Sep 2014
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Liatte Krueger, Namita Kothary
9 Sep 2014
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Liatte Krueger, Namita Kothary
9 Sep 2014
21 CFR 314.80(e)(2)
Failure to identify post marketing study reports
Cited by Liatte Krueger, Namita Kothary
Investigators
FDA investigators tied to this site in the record.
Nina Yang1 insp.
Byungja E Marciante1 insp.
Liatte Krueger1 insp.
Namita Kothary1 insp.
Denise M Visco1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(e)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Amarin Pharma 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