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.
The company also had no procedures in place for control of corrective and preventive actions relating to the NEO IXL and it lacked procedures to evaluate raw material suppliers for the products or to document any changes to the materials they supplied.
The facility also had no device master record for documents associated with specifications and manufacturing requirements for the product.
In addition, the company had no procedures for management reviews. The facility also lacked procedures for quality audits and failed to conduct audits at least annually.
Lastly, the agency official found the company lacked training records and had no procedures in place for training on SOPs or quality system regulations.
Read the Neo Innovations Form 483 here: www.fdanews.com/07-20-18-neoinnovations483.pdf. — Zack Budryk