AROA Biosurgery, LTD.

Summary

FDA record by year

AROA Biosurgery, LTD.'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

24 recall records from Apr 6, 2018 to Nov 27, 2018. Showing the 20 most recent. View all 24 recall records

Recent FDA inspections

1 inspection on Mar 9, 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

1 inspected site, newest inspection first.

Recent 510(k) clearances

10 510(k) clearances from Jun 14, 2017 to Jun 24, 2026.