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Quality system lapses — including process validation snafus — failure to address nonconforming products and not evaluating suppliers efficiently are some of the reasons contract device manufacturer Troy Innovative Instruments has fallen afoul of the FDA. Read More
The UK’s Medicines and Healthcare products Regulatory Agency, along with other European health regulators, have suspended CE certification for all products made by Brazilian implant maker Silimed after particle contamination was discovered during a facility inspection. Read More
Hospira’s Lake Forest, Ill., manufacturing facility received an FDA Form 483 for numerous quality system deviations related to its infusion pumps, including inadequate design validation, inadequate design change procedures and inadequate corrective and preventive action procedures. Read More
Round Rock, Texas-based Cardiac Designs received an Aug. 7 warning letter for design validation failures, inadequate complaint handling procedures and CAPA failures for its mobile heart monitoring device. Read More
Devicemaker Cepheid received an FDA Form 483 for design validation failures and inadequate medical device reporting procedures following a June 1 to 16 inspection at its Sunnyvale, Calif., manufacturing plant. Read More
The FDA handed Italian devicemaker Cane S.p.A. a warning letter for not including a software validation procedure in a Form 483 response, after the agency determined that production of the Crono S-PID-50 infusion pump did not comply with current good manufacturing practices. Read More
The FDA has hit Albany, N.Y.-based CMP Industries, a manufacturer of resins for dentures, with a warning letter for not adequately investigating “rust-like specks” found in one of its products, among other violations. Read More
A Swedish court has put temporary brakes on an order from the country’s Medical Products Agency that would require Medtronic to halt sales and recall its MiniMed 640G insulin pump. The stay will remain in place as Medtronic appeals the regulator’s actions before another court. Read More
The FDA and Centers for Disease Control and Prevention have advised healthcare facilities to strictly adhere to manufacturers’ instructions for use for reprocessing, as reports of improperly cleaned instruments continue to surface. Read More