Hong Kong Manufacturer’s Products Placed on Import Alert

Several good manufacturing practice violations and a lack of written procedures between a Hong Kong-based contract manufacturer and a U.S. devicemaker have resulted in an import alert on heating pads produced by Teamedics Manufacturing for HoMedics. The FDA cited Teamedics for not having a written agreement and procedures between it and HoMedics for device handling, investigation of nonconforming products and review of all activities to ensure that devices are manufactured in accordance with the device master record.
Devices & Diagnostics Letter