Stryker: Company Is in Compliance Following Warning Letter
Following its response to an FDA warning letter regarding its manufacturing facility in Cork, Ireland, Stryker considers its operations in full compliance with agency regulations, saying it has already employed the necessary corrective actions, the company told MQN.
The agency issued the letter March 15 to Stryker’s Ireland operations following inspections Oct. 31, 2006, to Nov. 3, 2006. The facility primarily manufactures Duracon and Scorpio knee replacement components, as well as hip replacement systems such as Trident Acetabular, according to the letter.
Stryker was cited for not appropriately documenting the required elements of risk analysis and root cause investigations and verification or effectivity measures regarding a correction for a packaging procedure, the letter said. In addition, a root cause investigation was not initiated and corrective and preventive actions (CAPAs) were not taken for a nonconformance of inner- and outer-blister test samples for lots of CoCr Hip Stems.
Stryker initiated a recall Nov. 29, 2006, for 1,768 stems manufactured at the Cork, Ireland, facility due to a packaging discrepancy, the company said. “The product itself and the packing issue did not pose any risks to patients and there were no reported adverse events,” Stryker said.
Operations at the Cork facility are proceeding as usual, the company said. Stryker told MQN that it does not expect any delays in product approvals as a result of the warning letter because there are no pending Class III medical device applications at the FDA from the site.
The letter can be accessed at www.fda.gov/foi/warning_letters/s6387c.pdf.