The GMP Letter

ORA and CDRH are developing a dedicated team for international device inspections. A similar program is already in place for pharmaceuticals and food, an FDA official said.

CDRH is working with the FDA’s Office of Regulatory Affairs (ORA) to close the time gap between agency inspections and warning letters, and to push for the issuance of more closeout letters.

The FDA has warned Meditherm for marketing its telethermographic camera for unapproved and uncleared uses.

Fresenius Medical Care Holdings has received an FDA warning letter for making uncleared design changes to a dialysis device that later led to a product recall.

Baltimore — As devicemakers await release of an electronic medical device reporting (eMDR) rule, some are using the time to give their complaint systems a facelift.

The FDA is launching a new recall website, making it easier for consumers to search and view product recall information.

The FDA has warned Philips Medical Systems for unvalidated and unverified corrective design changes, as well as its complaint handling procedures.

Avinger has received a Form 483 for failing to submit a medical device report (MDR) to the FDA after receiving information suggesting one of its devices may have led to patient injury.

The FDA has handed South African devicemaker Southern Implants a Form 483 that includes observations related to corrective and preventive action (CAPA) procedures.

Baton Rouge, La.-based Electro Medical Equipment has received a Form 483 with observations related to medical device reporting (MDR) procedures.

A final FDA guidance on requests for designation (RFD) of hard-to-classify combination products will help inform sponsors of what information should be included.

Rolling blackouts and transportation disruptions are among the problems facing devicemakers in Japan as they deal with the aftermath of a massive 9.0 earthquake and the ensuing tsunami.

Rising regulatory and operational costs are pushing some devicemakers to look for cheaper locations to set up shop — both domestically and overseas — as these comparative costs are ruling the corporate site selection process more than ever before, a recent study says.

Korean devicemaker Sometech has received an FDA warning letter for violations related to corrective and preventive actions (CAPA), complaint handling and documentation procedures.

ReBuilder Medical has been warned after an FDA inspection found no documentation of supplier qualification, despite a company requirement to test vendors’ product samples before approval.

The FDA has handed Chinese suture manufacturer ARC Medical Supplies a warning letter for cGMP violations related to documentation and recordkeeping.

CaridianBCT, a maker of blood cell separators and collection sets, has received an FDA warning letter citing GMP violations, such as problems following its sterility procedures.

To clarify a story in the March issue of The GMP Letter, a Form 483 received by Invacare in January cited failure to evaluate “complaints involving the possible failure of a device and labeling to meet any of its specifications.”