The GMP Letter

Although efforts to curb cargo and warehouse theft of medical products have paid off, greater vigilance is necessary to ensure the security of product, the FDA and industry experts say.

Boston Scientific is working with the FDA and law enforcement officials to recover endoscopy and urology equipment stolen while en route to a sterilization facility.

As regulatory agencies worldwide prepare regulations on unique device identification (UDI), Eucomed is pointing out benefits of the technology, as well as industry concerns, such as cost to devicemakers and deviations in its use.

Wisconsin Aluminum Foundry, a maker of steam sterilizers, lacks several necessary procedures, including procedures for complaint handling and evaluation, an FDA warning letter says.

The FDA may be setting itself up for litigation if it moves forward with a proposed device label repository, industry warns.

Consumer products giant Church & Dwight recently received a Form 483 with several observations related to medical device reporting (MDR) procedures.

DiaPharma Group, a West Chester, Ohio, company has received an FDA Form 483 with nine observations, five of which are repeats from a previous inspection.

The FDA’s San Francisco District Office handed AccessClosure a Form 483 with observations related to MDR report timing and procedures after a Feb. 14 to March 4, 2011 inspection.

The FDA has handed Korean devicemaker BNB Medical a warning letter for marketing its hair-removal devices in the U.S. without marketing clearance or approval.

American Contracts Systems (ACS) has received an FDA warning letter for failing to document validation activities or create procedures to control nonconforming product.

Nearly two months after a series of severe earthquakes hit Japan some devicemakers report modest increases in their first-quarter earnings as a result, while others lost millions.

The final rule on electronic medical device reports (eMDRs), on track for release this summer, will not be substantially different from the draft that preceded it two years ago, despite industry concerns, FDA officials tell GMP.

The FDA has warned Medrad saying there is no evidence the company submitted a correction and removal report for several corrections to a product.

A substantial increase in the number of field safety notices issued by UK devicemakers in the last five years is leading to calls for greater transparency and more clinical data for devices.

ASI Medical was handed a warning letter for failing to follow several of its own standard operating procedures (SOPs), including one on quality control exception reports.

Zevex International has received an FDA warning letter citing problems with its corrective and preventive action (CAPA) procedures and software fixes.