The GMP Letter

The FDA’s work toward tighter supply chain control through international regulatory cooperation is falling short, but a new global strategy may speed up the agency’s progress, a top FDA official says.

CDRH has formed a new team to improve the timeliness and quality of recall reports submitted by industry.

Medtronic has successfully resolved issues cited in two 2009 warning letters to its Mounds View, Minn., and Juncos, Puerto Rico, facilities.

Analysts see an upcoming market-share shakeup for drug-eluting coronary stents, with Johnson and Johnson’s (J&J) Cordis division taking the short straw after manufacturing troubles.

Invacare has been handed a pair of Form 483s that cite a host of issues, including medical device report (MDR) failures.

The FDA has handed B. Braun Medical a Form 483 after making five observations at its Carrollton, Texas, facility, including finding the company modified devices without reporting to the FDA.

North Brunswick, N.J.-based Artegraft has been handed a Form 483 by the FDA following a Dec. 1, 2010, to Dec. 20, 2010, inspection.

Terumo Cardiovascular and two of its top executives have signed a consent decree of permanent injunction for several heart devices after GMP and reporting violations.

Swiss pharmaceutical giant Roche is recalling an insulin delivery system following concerns it could deliver the wrong dose to consumers.

As rolling blackouts continue to hit Japan following the recent earthquake, devicemakers are asking the Japanese government to prioritize the allocation of power supplies to medical device factories that manufacture mechanical ventilators, oxygen devices, defibrillators and other products vital for human life.

CDRH is growing increasingly concerned with the number of imported devices that lack sufficient U.S. entry data.

As DePuy Orthopedics, a Johnson and Johnson (J&J) company, faces numerous lawsuits, recalls and an FDA investigation, its CEO David Floyd has called it quits.

The FDA has handed DiaPharma Group a warning letter for a number of violations related to cGMPs.

As the FDA continues hammering the importance of supplier qualification, it has handed Nanotherapeutics a warning letter citing failure to complete the vendor qualification required by the company’s procedures.

The FDA has approved the use of Covidien’s South African-made molybdenum-99 (Mo-99), used to generate a widely used diagnostic.

IRVING, Texas — Devicemakers are growing increasingly frustrated over the FDA’s inconsistency when it comes to defining which companies must follow the quality system (QS) regulation.

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.

Friendswood, Texas-based Iso-Tex Diagnostics has been handed an FDA warning letter for GMP violations related to radiopharmaceutical diagnostic agents.

An Illinois maker of breast pumps and baby-feeding accessories received an FDA warning letter following instances of improperly handling reports of smoke coming from devices.

A Washington, D.C., law firm is pushing for the FDA to create a website that will disclose more information on legal enforcement actions involving the agency.

As the FDA prepares to release its proposed rule for a unique device identifier (UDI) database, devicemakers are off the hook for UDI label scrutiny during premarket review.

Steris has an additional six months to transition facilities that use its SYSTEM 1 for sterile reprocessing to an alternative reprocessing method, a switch required by an FDA consent decree.

Novartis subsidiary CIBA Vision has been handed an FDA warning for cGMP violations and product sterility issues.

Baltimore — The reformation of the Global Harmonization Taskforce (GHTF) without industry participants may threaten industry and regulator input on an international design and manufacturing standard.

Citing a dramatic spike in thefts of medical devices and prescription drugs, a group of democratic senators March 8 introduced federal legislation to crack down on medical product heists at every point in the supply chain.

EU regulators and industry are calling for enhanced traceability and global device standards following recent FDA criticism.