BioMarin Pharmaceutical, Inc. FDA Record

Summary

FDA record by year

BioMarin Pharmaceutical, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for BioMarin Pharmaceutical, Inc. above.

BioMarin Pharmaceutical, Inc. and the FDA: common questions

Has BioMarin Pharmaceutical, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "BioMarin Pharmaceutical, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has BioMarin Pharmaceutical, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "BioMarin Pharmaceutical, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect BioMarin Pharmaceutical, Inc.?

The most recent FDA inspection on file ended Jun 9, 2026 at Novato, CA and was classified VAI. FDA has 16 inspections of BioMarin Pharmaceutical, Inc. on file.