FDA 483 - W & R Investments LLC d.b.a. Laser Engineering - October 13, 2022

An FDA inspection of W & R Investments LLC d.b.a. Laser Engineering in Milford, MA, identified a significant issue with the firm's complaint handling procedures. The company failed to establish adequate procedures for receiving, reviewing, and evaluating complaints, specifically lacking a time-frame objective for complaint file closure. This deficiency led to numerous complaint files remaining open for extended periods, potentially resulting in missed Medical Device Reports (MDRs).