Overview
- 19 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-26.
At a glance
Inspections
19
Form 483s
11
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Mar 2025 – 26 Mar 2025 | Biologics | Clean | |
| 30 Jul 2024 – 19 Aug 2024 | Human Drugs | 483 | On file |
| 5 Dec 2022 – 9 Dec 2022 | Biologics | 483 | On file |
| 25 Mar 2021 – 2 Apr 2021 | Human Drugs | 483 | On file |
| 5 Nov 2018 – 9 Nov 2018 | Human Drugs | 483 | On file |
| 4 Dec 2017 – 14 Dec 2017 | Human Drugs | 483 | On file |
| 2 Nov 2016 – 4 Nov 2016 | Human Drugs | Clean | |
| 22 Aug 2016 – 25 Aug 2016 | Human Drugs | 483 | On file |
| 8 Apr 2014 – 17 Apr 2014 | Human Drugs | 483 | On file |
| 16 Sep 2013 – 24 Sep 2013 | Human Drugs | 483 | On file |
| 24 Jun 2013 – 28 Jun 2013 | Human Drugs | Clean | |
| 3 Nov 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Jolanna A Norton2 insp.
Ashar P Parikh2 insp.
Lance M De Souza2 insp.
Priscilla M Pastrana1 insp.
Richard L Bartlett1 insp.
Laura Fontan1 insp.
Thomas R Withers1 insp.
Andrew W Harmon1 insp.
Emmanuel Adu-Gyamfi1 insp.
Kula N Jha1 insp.
Uttaniti Limchumroon1 insp.
Hung H Do1 insp.
Yiyue Zhang1 insp.
Dustin P Tran1 insp.
Zhou Chen1 insp.
Joslyn K Brunelle1 insp.
Ying Xin Fan1 insp.
Sherri J Jackson1 insp.
Candace Y Gomez-Broughton1 insp.
Anh Lac1 insp.
Thomas J Arista1 insp.
Aneel K Sandhu1 insp.
Eileen A Liu1 insp.
Uduak M Inokon1 insp.
Jeffrey M Watson1 insp.
Henry K Lau1 insp.
Carl Lee1 insp.
William V Millar1 insp.
Rochelle B Young1 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 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Biomarin Pharmaceutical Inc.'s 11 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