An import alert has been placed on heating pads produced by Teamedics Manufacturing for HoMedics.

The import alert was handed down by the FDA after the agency discovered that Teamedics did not have a written agreement and procedures between itself and HoMedics for device handling, investigations of nonconforming products and review of all activities to ensure that devices are manufactured in accordance with the device master record.

The FDA cited Teamedics for failing to perform process validation for the semi-automated PVC welders used to weld the edges of the heating pads. The company also did not perform process validation on the semi-automated PVC electrical cord welders. “Your firm was unable to produce a written procedure to indicate you had established monitoring and control of these processes,” the letter said.

Teamedics also was cited for failing to establish and maintain written corrective and preventive action (CAPA) procedures, and failing to establish and maintain a design history file for each type of device.

“Your firm stated you maintain documents for two years after which time the documents, including the design file, are thrown away,” the FDA’s letter said. “The investigator was unable to review any design documentaion including design changes. Your firm stated that the last design change was more than four years ago.”

Other violations cited by the FDA include:

• Failing to document instructions, standard operating procedures, and methods that define and control the manner of production of the medical device
• Failing to establish and maintain written procedures for acceptance activities including inspections, test, or other verification activities
• Failing to establish and maintain written procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality
• Failing to ensure that all inspection, measuring, and test equipment is suitable for its intended purpose and capable of producing valid results
• Failing to establish and maintain adequate procedures to control  or dispose of product that does not conform to specified requirements
• Failing to adequately maintain device history records
• Failing to retain records for a period of time equivalent to the design and expected life of the device, but in no case less than two years from the date of release for commercial distribution
• Failing to establish and maintain data that clearly describe or reference the specified requirements