Stryker Corp., maker of orthopedic devices, received another warning from the U.S. Food and Drug Administration related to quality issues and false documents.
Shares of Stryker Corporation fell 3.20 percent to $63.58 in the New York stock Exchange by 3:51 p.m. Earlier shares dropped to $62.57 or 4.7 percent decline, the largest since March 10.
The warning, sent to the Stryker Biotech division, represents the third letter the FDA has sent to the company. The regulatory authority referred to falsified documents delivered to hospital boards by sales representatives of the firm.
According to Stryker, the documents had to gain approval of the boards for experimental products made in the Hopkinton, Mass., unit, according to Aaron Kwittken a company spokesman. The sales representatives are no longer part of the company, Kwittken added.
The product is a bone growth promoter called OP-1 Putty for patients in spinal fusion, same which is made of human protein powder and cow collagen. The product was sent to the FDA in 2006 for approval but the process has been delayed.
Another aspect addressed by the FDA is deficiency in a previous clinical study and bad quality systems. However the group said it has already taken steps to fix the quality systems, establish operating procedures and give senior management compensation to resolution of problems.
Stryker received two more FDA warning letters, one in March 2007 and the second in January 2008.