FDA 483 - PC Marketing, Inc. - January 19, 2017

P.C. Marketing, Inc., an importer and initial distributor of sunlamp products in Ridgefield, NJ, was cited for significant deficiencies in its quality system and medical device reporting procedures. The inspection revealed a lack of established procedures for various operations, inadequate complaint handling, and failure to report device malfunctions, including multiple instances of tanning beds catching fire. Additionally, issues with organizational structure, acceptance activities, and incorrect user manual labeling for sunlamp products were noted.