A Medical Device Daily
The FDA has sent Stryker (Kalamazoo, Michigan) a warning letter, saying the artificial hip and knee maker has not completed promised fixes at a plant in Carrigtoholl, Ireland, the company's second largest orthopedic manufacturing plant worldwide, and its largest in Europe. The seven-page letter from the FDA cited several violations, including missed deadlines to fix failures in following procedures for testing problematic products, documenting risk analysis, among other issues.
The letter, posted on the agency's web site yesterday, is dated March 15, and is heavily redacted, but it refers to a voluntary recall of "hip fracture stems" that the company completed earlier this year, which appears to be related to the problems.
The warning letter claims the various methods, facilities and controls used, packaging, storage and installation were not in conformity with the Current Good Manufacturing Practice of the FDA's Quality System regulation.
Though Stryker replied to the FDA's comments (following the plant inspection), the March 15 Warning Letter claimed the responses were deficient based on several reasons including 1) incomplete corrective actions, 2) failure to properly describe corrective measures to be taken, and 3) insufficient detail and description of the actions/steps to be taken.
Rick Wise, a med-tech analyst for Bear Stearns wrote in a research note that based on the feedback from the FDA, Stryker's inadequate reaction to the FDA's inspection "appears to be mainly communication related." He added that had the company provided the FDA with a more descriptive account of its remedial actions, "we think the FDA's warning letter language may have been peeled back a bit or not issued."