FDA 483 - Venus Concept Inc - January 16, 2020

On January 16, 2020, the FDA issued a Form 483 to Venus Concept Inc., a medical device manufacturer located at 128 Baytech Dr, San Jose, CA. The inspection, conducted from January 13-16, 2020, identified two observations related to the firm's quality system.

Observation 1 noted inadequate documentation of corrective and preventive action (CAPA) activities and results. A review of 12 CAPAs from May 2017 to present revealed that 8 were not adequate per the firm's SOP-1052, Revision: K. Specifically, 2 CAPAs were logged but uninvestigated for months, 5 were not closed within the procedural timeframe, and 7 lacked investigation details or justifications for time extensions.

Observation 2 cited inadequately maintained complaint files. A review of 13 complaints from May 2017 to present, against SOP-1126, Revision: T, showed deficiencies. One complaint was delayed in QA/RA reporting, one received months prior remained uninvestigated, 4 lacked investigation details, and 3 were incorrectly marked "no" for malfunction evaluation despite device malfunction.

Mark L. Hair, Chief Integration Officer, was issued the report. The firm "promised to correct" both observations. The FDA emphasized that the observations are not exhaustive and the firm is responsible for internal self-