The GMP Letter

Virtually all devicemakers surveyed by the FDA blame the agency in part for low-quality products reaching market.

The third quarter of 2011 saw 290 recalls involving nearly 30 million units of device and diagnostic products, consultants with ExpertRECALL, an industry recall consultancy, said.

A new government report cites the device industry’s lack of cooperation with the FDA as one barrier the agency faces in its quest to tighten the world’s complex medical device supply chain.

Stepped-up, litigious FDA enforcement is having a “paralyzing effect” on devicemakers’ good-faith compliance efforts, device defense lawyers say.

CooperVision’s recent expansion of a contact lens recall will have long-term negative effects only if FDA investigations turn up other significant problems, contact lens consultant Ralph Stone said in a Nov. 16 Wells Fargo Securities conference call.

Zimmer displayed slack design validation on a pair of hip implants, according to an FDA Form 483.

Knowledge of sterilization failures and failure to remedy them were among violations at Bayamon, Puerto Rico-based Biolab, an FDA Form 483 and subsequent warning letter state.

FDA inspectors cited Advanced Neuromodulation Systems for failing to submit medical device reports (MDR) within 30 days.

FDA investigators closed an inquiry into a Virginia devicemaker based on the company’s corrective actions, according to a June 8 closeout letter.

The U.S. Supreme Court refused to hear Stryker’s appeal on the company’s Trident hip implant Oct. 31, allowing a lower court’s ruling to stand.

Devicemakers should have senior managers directly oversee suppliers, build feedback loops across company quality systems and instill a mindset dedicated to quality, according to a new report.

Amid continuing concern that breaks in the global supply chain will beget another heparin crisis, FDA inspectors are upping scrutiny of drug and device manufacturers’ supplier controls to ensure they are sufficiently robust and clearly articulated in scientific terms, agency officials say.

Device-related adverse events rose 13 percent to 10,280 in the UK during 2010, according to the Medicines and Healthcare products Regulatory Agency (MHRA).

CDRH hasn’t taken special steps to protect consumers from goods adulterated for economic reasons, the Government Accountability Office (GAO) says.

Twenty models of St. Jude Medical defibrillator leads may put patients at risk of electrical abnormalities as a result of insulation failure, the company warned doctors.