Fenwal International, Inc. FDA Record

Summary

FDA record by year

Fenwal International, 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.

Fenwal International, Inc. FDA Warning Letters

4 warning letters from Jun 1, 2012 to Sep 14, 2023.

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.

Fenwal International, Inc. Form 483s

1 Form 483 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

18 inspections from Feb 2, 2009 to Feb 5, 2026.

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 4 compliance actions under Fenwal International, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 14, 2023.

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

3 inspected sites, newest inspection first.

Fenwal International, Inc. and the FDA: common questions

Has Fenwal International, Inc. received an FDA warning letter?

Yes. FDA has issued 4 warning letters to Fenwal International, Inc.. The most recent is dated Sep 14, 2023.

Has Fenwal International, Inc. received an FDA Form 483?

FDA has published 1 Form 483 for Fenwal International, Inc. in its reading room, the most recent dated Sep 18, 2024. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Fenwal International, Inc.?

The most recent FDA inspection on file ended Feb 5, 2026 at Maricao, PR and was classified VAI. FDA has 18 inspections of Fenwal International, Inc. on file, 4 of them classified OAI (official action indicated).