www.fdanews.com/articles/113604-contract-manufacturer-warned-for-gmp-violations-stryker-recall-follows
Contract Manufacturer Warned for GMP Violations, Stryker Recall Follows
January 9, 2009
Contract Medical Manufacturing (CMM) shipped finished devices without ensuring they met sterilization criteria and failed to investigate complaints of patients who developed infections, according to an FDA warning letter.
The company, which produces custom cranial implants for Stryker, voluntarily stopped shipment of the devices during the FDA’s inspection of its Oxford, Conn., plant last September, the letter says.
Stryker recalled the implants in late October because their sterility could not be assured. The devices are designed individually for each patient to correct trauma or defects in the upper and lower jaw, face and cranium. CMM said shipment of the devices remains halted.
The GMP Letter
The company, which produces custom cranial implants for Stryker, voluntarily stopped shipment of the devices during the FDA’s inspection of its Oxford, Conn., plant last September, the letter says.
Stryker recalled the implants in late October because their sterility could not be assured. The devices are designed individually for each patient to correct trauma or defects in the upper and lower jaw, face and cranium. CMM said shipment of the devices remains halted.
The GMP Letter