Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-11-06.
At a glance
Inspections
4
Form 483s
3
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Oct 2020 – 6 Nov 2020 | Human Drugs | 483 | On file |
| 24 Feb 2020 – 28 Feb 2020 | Human Drugs | 483 | View 483 → |
| 4 Dec 2017 – 7 Dec 2017 | Human Drugs | Clean | |
| 11 Feb 2014 – 17 Feb 2014 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Feb 2020
21 CFR 314.80(c)(2)
Late submission of annual safety reports
Cited by Karen M Montgomery, Stephen T Hansen, Dustin P Tran, Haley H Seymour, Dipti Kalra
Investigators
FDA investigators tied to this site in the record.
Sandra S Saniga1 insp.
Karen M Montgomery1 insp.
Stephen T Hansen1 insp.
Dustin P Tran1 insp.
Haley H Seymour1 insp.
Dipti Kalra1 insp.
Lauren E Swantko1 insp.
Stephanie A Slater1 insp.
Lance M De Souza1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Biomarin Pharmaceutical, Inc.'s 3 Form 483s
Source PDFs 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