Smith & Nephew has received an FDA warning letter over quality control concerns arising from a July inspection of the company's Tuttlingen, Germany facility. The devicemaker had sent a response to the agency in August concerning the observations seen at the facility, which makes hip implants, but the FDA deemed it inadequate.
In the Dec. 21 letter, the FDA maintains that required tests were not performed and the company had failed to establish and maintain procedures to correct problems in the manufacture of the R3 ceramic acetabular system, a hip replacement device. The letter highlights one instance in which the company implemented new packaging procedures and retrained employees following problems with irradiation. In spite of the company's actions, problems continued. "The firm's management stated that the recurring nonconformities may be attributed to employees not following directions," the letter states.
The devicemaker said it had not yet seen the contents of the letter but had taken remedial action to solve issues raised by the FDA . "The device is also made in Warwick, UK, and Memphis so there is no problem in supply," a company spokesman said. He added there had been no reports of patient incidents, Reuters notes.
Bloomberg reports that Smith & Nephew fell the most in six months in London trading after the letter was revealed.