Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-09-14.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Sep 2022 – 14 Sep 2022 | Human Drugs | Clean | |
| 16 Jan 2020 – 23 Jan 2020 | Human Drugs | Clean | |
| 7 Jul 2015 – 16 Jul 2015 | Human Drugs | 483 | View 483 → |
| 27 Aug 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Jul 2015
21 CFR 211.100(b)
SOPs not followed / documented
Cited by John P Mistler, Mary-Jeanet Mcgarry
16 Jul 2015
21 CFR 211.100(b)
SOPs not followed / documented
Cited by John P Mistler, Mary-Jeanet Mcgarry
16 Jul 2015
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by John P Mistler, Mary-Jeanet Mcgarry
16 Jul 2015
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by John P Mistler, Mary-Jeanet Mcgarry
16 Jul 2015
21 CFR 211.198(b)(1)
Complaint Record required information
Cited by John P Mistler, Mary-Jeanet Mcgarry
Investigators
FDA investigators tied to this site in the record.
Matthew C Watson2 insp.
Michael Serrano1 insp.
John L Zaccone1 insp.
John P Mistler1 insp.
Mary-Jeanet Mcgarry1 insp.
Alan R Condon1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Aegerion Pharmaceuticals, Inc.'s 1 Form 483
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