Stryker hit with FDA warning

STRYKER Ireland’s plant at Carrigtwohill, Co Cork, has been warned by the powerful US Food and Drugs Administration (FDA) to correct production failings.

The Irish operation makes devices such as hip and knee replacements and has been subjected to two separate FDA inspections in October and November of 2006.

It employs around 350 people and opened in 1998.

Details of the investigation posted on the FDA website yesterday noted the firm had so far failed to carry out the improvements listed for correction in the two reports carried out the by FDA.

The seven-page letter to Stryker in the US listed several violations, missed deadlines to fix procedures for testing products produced at the plant that were problematic as well as a failure to document risk analysis.

Stryker in Carrigtwohill was not available for comment yesterday.

Stryker has two other plants located in Raheen, Co Limerick which also makes orthopaedic replacement devices and employs around 600.

The FDA said while the firm agreed to change procedures at the Cork plant they have not been carried out yet.

Stryker started operations in Carrigtwohill in November 1998. Stryker Ireland is a division of Stryker Corporation, which has its global headquarters in Michigan.

It has a global workforce of 16,000 and total sales of $4.9 billion (€3.6 billion) in 2006. It is a leading manufacturer of medical products to make surgery more efficient, reduce trauma and improve surgical techniques.

In the quarter ending March, the parent company earned $243.5 million (€178.5 million), or 59 cents a share, compared with $147.5m, or 36 cents a year earlier.