Infinium Medical, Inc FDA Record

Summary

FDA record by year

Infinium Medical, 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 recalls

1 recall record on May 31, 2019.

Recent FDA inspections

4 inspections from Oct 15, 2012 to Nov 8, 2023.

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.

Recent 510(k) clearances

7 510(k) clearances from Aug 11, 2010 to Aug 14, 2026.

Infinium Medical, Inc and the FDA: common questions

Has Infinium Medical, Inc received an FDA warning letter?

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

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

When did the FDA last inspect Infinium Medical, Inc?

The most recent FDA inspection on file ended Nov 8, 2023 at Largo, FL and was classified VAI. FDA has 4 inspections of Infinium Medical, Inc on file.

Has Infinium Medical, Inc had an FDA recall?

Yes. Infinium Medical, Inc has 1 FDA recall on record. The most recent started May 31, 2019.