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Latest From Integra LifeSciences
EU Enforcement in Brief
European authorities found several facilities out of compliance with their GMP requirements. One used tweezers to remove contaminants it should have prevented, another boarded up a non-compliant storage room, a third lacked data integrity and a fourth had data integrity and sterility assurance issues.
Integra Resolves Warning Letter On Puerto Rico Facility
The 2013 letter cited violations related to the company’s manufacturing facility in Añasco, which are now resolved. The company says it has made major investments in improving its quality systems.
Integra LifeSciences Aims To Shutter Two Plants, Discontinue Low-Growth Products
The plans are part of a strategy to consolidate manufacturing operations while prioritizing fast-growing, high-margin regenerative medicine products.
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