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The FDA inspector noted that design validation for the Xpert MRSA diagnostic test did not ensure that the device conforms to defined user needs and intended uses. Read More
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
Olympus is facing tough questions from the FDA following inspections conducted in April and May of four facilities that manufacture duodenoscopes. The company — along with Pentax and Fujifilm — is facing scrutiny after improper cleaning of its complex endoscopes was linked to patients becoming sick or dying. Read More
The FDA handed Italian devicemaker Canè 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 UK’s Medicines and Healthcare products Regulatory Agency has successfully prosecuted two companies it says supplied defective prefilled syringes whose use resulted in a diabetic patient’s death in 2010. Read More