FDA Flags Neo Innovations for Complaint Handling, MDRs

The FDA issued a Form 483 to class II device manufacturer Neo Innovations over design controls, medical device reporting and complaint procedures.

The agency issued the 11-observation 483 following an April inspection of the firm’s Pueblo, Colorado facility. The investigator found the firm had no design control procedures in place for control of its class II IPL/Xenon Tattoo Removal Device and it had no design history file for the product.

Investigators also found the firm had no procedures in place for medical device adverse events or for handling evaluating complaints related to the NEO IXL tattoo removal kit.