The GMP Letter

Sen. Sherrod Brown (D-Ohio) had harsh criticism for FDA Commissioner Margaret Hamburg at a recent Senate hearing, questioning the agency’s lack of enforcement actions against device and drug companies with holes in their supply chain knowledge.

The FDA and other agencies must provide expertise, training and tools to developing nations to improve their medical technology monitoring practices and prevent dangerous medical products from entering the U.S., according to an Institute of Medicine (IOM) report.

Lax documentation of testing failures and inadequate design history files for Novalung’s surgical Lung Assist device has resulted in an FDA warning letter for the German company.

The FDA’s recently deployed computer system that ranks imports according to risk was praised in a new government report, but a former agency official says it’s essentially stuck in neutral, citing the report’s chiding remarks about FDA sluggishness in integrating its legacy IT systems.

The FDA has escalated a long-simmering dispute with Israeli-owned software developer NeuroTrax about the proper classification for its MindStreams cognitive health assessment tool, telling the company in a warning letter it must seek Class III status or halt marketing the product.

Sonic Innovations is taking a more conservative view of FDA regulations on reportable events after getting an FDA Form 483 for lapses in complaint handling and reporting procedures.

Frontier Medical Products is once again under the FDA’s microscope for a lack of trained auditors at the company and failure to perform internal quality audits.

A Form 483 to Midmark Corporation finds fault with corrective and preventive action (CAPA) procedures at its Versailles, Ohio, facility, as the plant did not analyze complaints for devices if they failed after the warranty period.

A bevvy of concerns about complaint handling and corrective and preventive action (CAPA) procedures led to an FDA warning letter for wheelchair-lift maker ThyssenKrupp Access Manufacturing.

A scientific journal has rejected St. Jude Medical’s demand that it retract a report linking two of its heart leads with patient deaths.