Biohaven Pharmaceuticals, Inc FDA Record

Summary

FDA record by year

Biohaven Pharmaceuticals, 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.

Recent FDA inspections

3 inspections from Nov 7, 2019 to Apr 24, 2025.

NAI

No objectionable conditions or practices were found during the inspection.

VAI

Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

OAI

Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Biohaven Pharmaceuticals, Inc and the FDA: common questions

Has Biohaven Pharmaceuticals, Inc received an FDA warning letter?

No FDA warning letter addressed to the name "Biohaven Pharmaceuticals, 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 Biohaven Pharmaceuticals, Inc received an FDA Form 483?

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

When did the FDA last inspect Biohaven Pharmaceuticals, Inc?

The most recent FDA inspection on file ended Apr 24, 2025 at New Haven, CT and was classified NAI. FDA has 3 inspections of Biohaven Pharmaceuticals, Inc on file.