BPI Labs FDA Record

Summary

FDA record by year

BPI Labs'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.

BPI Labs FDA Warning Letters

1 warning letter on Mar 20, 2025.

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

BPI Labs Form 483s

3 Form 483s published by FDA.

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

4 inspections from Jun 12, 2019 to Apr 23, 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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under BPI Labs: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Mar 20, 2025.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

2 inspected sites, newest inspection first.

BPI Labs and the FDA: common questions

Has BPI Labs received an FDA warning letter?

Yes. FDA has issued 1 warning letter to BPI Labs. The most recent is dated Mar 20, 2025, with the subject "Unapproved New Drugs/Misbranded".

Has BPI Labs received an FDA Form 483?

FDA has published 3 Form 483s for BPI Labs in its reading room, the most recent dated Apr 17, 2026. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect BPI Labs?

The most recent FDA inspection on file ended Apr 23, 2025 at Largo, FL and was classified VAI. FDA has 4 inspections of BPI Labs on file.