Stryker Boosts GMP Compliance Spending, Again

Stryker plans to increase GMP compliance-related spending by as much as $40 million this year as it continues its efforts to remediate quality system issues.

Multiple warning letters and a temporary production stoppage last year for its hip replacement implants forced Stryker to implement a global, corporatewide GMP compliance program, which cost an additional $50 million to $55 million in 2008.

During the company’s year-end earnings call, Vice President Katherine Owen told analysts that despite the company’s efforts to fix its manufacturing issues — spurred by the receipt of three warning letters — Stryker’s supplier controls programs need more attention. “We still have work to do as evidenced by the [fourth-quarter] recall of one of our [Craniomaxillofacial] products,” Owen said.
The GMP Letter