FDA 483 - Trigg Laboratories, Inc. - February 12, 2020

Trigg Laboratories, Inc. dba Wet International in Las Vegas, NV, was inspected and received a Form FDA 483 with four observations. The inspection revealed significant issues including inadequate procedures for microbial testing and product defect investigations, failure to maintain complaint files, lack of adequate process controls for environmental conditions and equipment cleaning, and insufficient statistical techniques for product acceptance. These findings indicate a lack of robust quality system controls for medical device manufacturing.