PATH FDA Record

Summary

FDA record by year

PATH'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 recalls

5 recall records from Sep 26, 2023 to Nov 6, 2025.

Recent FDA inspections

3 inspections from Jan 26, 2010 to May 17, 2017.

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

2 inspected sites, newest inspection first.

PATH and the FDA: common questions

Has PATH received an FDA warning letter?

No FDA warning letter addressed to the name "PATH" 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 PATH received an FDA Form 483?

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

When did the FDA last inspect PATH?

The most recent FDA inspection on file ended May 17, 2017 at Germering, Germany and was classified NAI. FDA has 3 inspections of PATH on file.

Has PATH had an FDA recall?

Yes. PATH has 5 FDA recalls on record. The most recent started Nov 6, 2025.