By Jon Kamp
Of DOW JONES NEWSWIRES
Stryker Corp. (SYK) has resolved one of four warning letters issued by the Food and Drug Administration in recent years due to issues found at company plants, the medical device-maker said Tuesday.
The resolved letter was issued to the company's Biotech division in 2008 regarding a Massachusetts plant where Stryker makes a product that promotes bone growth. Issues cited by the FDA included falsification of hospital-approved documents under an FDA rule that allows device sales on a very limited basis.
While Stryker still has three more letters to address, resolving the Biotech issue is "an important first step" toward the company's goal of full resolution, Stryker Chief Executive Stephen P. MacMillan said on a conference call following the company's third-quarter earnings release.
He announced on the call that the letter was resolved following an FDA re-inspection earlier this year.
Shares of the Kalamazoo, Mich., company traded up 3.4% to $46.80 after hours on Tuesday after slipping 1.9% during regular trading.
The FDA issues warning letters when it finds problems at company facilities. Such letters can take years and millions of dollars to resolve while blocking approval for new products.
Stryker is spending more than $200 million over three years to improve its quality and compliance systems.
Of the three other warning letters, two from 2007 are related to plants in Ireland and New Jersey where Stryker makes reconstructive orthopedic implants. The third letter - the one it received most recently - relates to cranial implant kits that Stryker no longer sells.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728; jon.kamp@dowjones.com