Overview
- 12 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-22.
At a glance
Inspections
12
Form 483s
6
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 May 2025 – 22 May 2025 | Human Drugs | Clean | |
| 23 Apr 2019 – 26 Apr 2019 | Human Drugs | Clean | |
| 2 Jul 2018 – 6 Jul 2018 | Biologics | 483 | On file |
| 4 Sep 2017 – 12 Sep 2017 | Human Drugs | 483 | View 483 → |
| 11 Jan 2016 – 20 Jan 2016 | Biologics | 483 | On file |
| 30 Jun 2014 – 8 Jul 2014 | Human Drugs | 483 | View 483 → |
| 29 Apr 2014 – 6 May 2014 | Biologics | 483 | On file |
| 18 Sep 2012 | Not recorded | 483 | On file |
| 12 Jul 2010 | Not recorded | Clean | |
| 10 Jun 2008 | Not recorded | Clean | |
| 21 Mar 2002 | Not recorded | Clean | |
| 25 Jan 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Sep 2017
21 CFR 211.100(a)
Approval and review of procedures
Cited by Shawn E Larson, Susan T Hadman
12 Sep 2017
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Shawn E Larson, Susan T Hadman
12 Sep 2017
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Shawn E Larson, Susan T Hadman
12 Sep 2017
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Shawn E Larson, Susan T Hadman
12 Sep 2017
21 CFR 211.68(b)
Computer control of master formula records
Cited by Shawn E Larson, Susan T Hadman
Investigators
FDA investigators tied to this site in the record.
MRA M BarbosaR1 insp.
MRA McCulloughJ1 insp.
Arie Menachem1 insp.
Xiaokuang Lai1 insp.
Shawn E Larson1 insp.
Susan T Hadman1 insp.
Cynthia Jim1 insp.
Uttaniti Limchumroon1 insp.
Jeremy L Wally1 insp.
Qiao Y Bobo1 insp.
Mihaly S Ligmond1 insp.
Barbara M Frazier1 insp.
Michelle Y Clark Stuart1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ipsen BioPharm Ltd's 6 Form 483s
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