Stryker Corp., the Kalamazoo-based manufacturer of artificial hips and nees, hospital beds and other medical gear, said Friday it had received a warning letter from the United States Food and Drug Administration about violations at its Hopkinton, Mass. biotech division.

The letter alleges the company falsified documents and failed to control quality at the plant. The warning letter concerns observations made during an inspection that was initiated last September.

The letter primarily cites issues relating to Stryker Biotech's handling of a past clinical study, its quality system including medical device reporting procedures, and the integrity of hospital institutional review board documentation used to approve implantation of humanitarian use devices.

According to the Detroit Free Press, the falsified documents charge refers to material submitted to the hospital boards by Stryker sales representatives, material required to gain approval by the boards for experimental products made in Hopkinton to be implanted  in patients.

Stryker said several corrective actions and changes to processes put in place by Stryker Biotech were noted in the letter and future improvements are forthcoming as the division continues to work with FDA. No products have been recalled as a result of this warning letter. In addition, there were no observations related to any ongoing clinical trials or clinical trial IRBs.

"We take this matter very seriously, will continue to cooperate fully with FDA, and have initiated significant measures to address FDA's concerns," said Stryker president and CEO Stephen P. MacMillan.

In addition to specific corrective actions implemented at the Biotech division, Stryker recently launched a company-wide Quality Action Plan aimed at strengthening corporate-level oversight and at institutionalizing a more consistent implementation of best practices for meeting FDA requirements.

More at www.stryker.com.