TEN ACES MEDICAL ADHESIVE SPRAY

Description of Event or Problem

WE CONDUCTED A TEST PURCHASE OF TEN ACES MEDICAL ADHESIVE REGISTRATION NUMBER (B)(4). THE PRODUCT WAS SHIPPED TO US WITHOUT THE REQUIRED HAZMAT SHIPPING LABELS, IN VIOLATION OF DOT AND USPS REGULATIONS. WE ALSO FOUND THAT THE PRODUCT WAS MISSING AN EXPIRATION DATE AND BATCH NUMBER. BASED ON THIS, AND OUR COMMUNICATIONS WITH THE MANUFACTURER, WE SUSPECT THEY MAY BE MANUFACTURING MEDICAL DEVICES WITHOUT A QUALITY MANAGEMENT SYSTEM. TEN ACES MEDICAL IS A NEW COMPANY AND MAY NOT UNDERSTAND THEIR DUTIES AS A MEDICAL DEVICE MANUFACTURER.