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Burlington, Mass.- based LeMaitre Vascular drew a lengthy Form 483 from the FDA for failing to follow the company’s own corrective and preventive action (CAPA) procedure and to control nonconforming product, among other lapses.
The FDA has issued a warning letter to Tokyo-based endoscope manufacturer Olympus Medical Systems for failing to establish procedures to implement corrective and preventative actions as well as a lack of process validation for product changes, among other lapses.
As part of its Medical Device User Fee Amendments (MDUFA) goals for 2023-2027, the FDA’s Center for Diagnostic and Radiological Health (CDRH) has added new functions to its portal where device sponsors can send in and track their premarket submissions.
Pain and bleeding were reduced in a clinical trial testing Aspivix’s Carevix cervical stabilizer device against a standard tenaculum — used to stabilize the cervix to ease passage of instruments — among women undergoing intrauterine device (IUD) placement to prevent pregnancy.
North Carolina-based Carolina Biological Supply was handed a Form 483 for lacking adequate procedures for corrective and preventative actions (CAPA), medical device reporting (MDR) and audits, among other lapses.