You've been warned: This week in FDA med tech violations

This week the FDA disclosed a number of warning letters issued in the med tech space, affecting an orthopedic implant maker, a laser-device company, a biological reagents outfit and a therapeutic massager device operation, among others. Here's a roundup of the companies and their respective violations:

  • Hyphen Biomed. The FDA cited the maker of Class II biological reagents for hemostatis and thrombosis for various quality-system violations, based on an inspection of Hyphen's operations in Neuville-sur-Oise, France, from June 18-20, 2012. More
  • Instratek. Based in Houston, TX, this manufacturer of orthopedic implants and surgical instruments for the hand and foot faced an FDA inspection from April 2-24, 2012. Based on that effort, regulators cited the company for quality-system violations, which included lacking adequate procedures to correct and prevent future manufacturing problems. More
  • Fisioline. This Italian laser-device company got smacked with an FDA warning letter for various quality-system violations, based on an Oct. 29-Nov. 1 inspection of its Verduno operations. Additionally, the FDA cited Fisioline for various Medical Device Reporting violations. More
  • Body, Mind & Soul. Regulators cited the Canadian distributor of the Celluderm therapeutic massager for premarket approval violations for allegedly marketing the device for unapproved therapeutic uses. Product advertising recommended its use to stimulate the lymphatic system, reduce congestion and break up fat in the body, the FDA noted. Regulators inspected contract manufacturer Innovative Med before issuing their warning letter. More

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