The GMP Letter

Federal healthcare fraud enforcement in fiscal 2011 led to a record-breaking annual haul of about $4.1 billion, largely on False Claims Act (FCA) cases, the Justice Department and HHS say.

Speeding data disclosure is just one of eight proposals FDA Commissioner Margaret Hamburg is adopting as part of efforts to improve public access to compliance and enforcement data.

Inadequate procedures, particularly corrective and preventive action (CAPA) failures, have earned Canada-based Intelligent Hospital Systems (IHS) an FDA warning letter.

Johnson & Johnson’s (J&J) upcoming CEO switch, from Bill Weldon to devices business head Alex Gorsky, could signal the company’s confidence in its ongoing relaunch of McNeil Consumer Products, an analyst says.

California’s 2,000 biomedical companies face an extra layer of regulation: The state requires drug and device manufacturers to undergo an inspection by the California Food and Drug Branch in addition to federally mandated FDA inspections.

The FDA has handed telemetry maker ScottCare a warning letter for a host of GMP violations at its Cleveland, Ohio, plant, including improper implementation of corrective and preventive action (CAPA) procedures.

Thoratec, a California-based maker of heart disease-treating equipment, has received a Form 483 for failing to thoroughly investigate — and submit a timely MDR for — a complaint involving a patient death that may have resulted from a malfunction of one of its devices, a Form 483 states.

Undefined validation tests for key devices and a propensity to blame complainants when devices break has landed Numia Medical Technology an FDA Form 483.

Corrective and preventive action (CAPA) procedures at Biopsy Sciences’ Clearwater, Fla., facility do not ensure analysis of all quality data sources to identify “recurring” quality problems with its HydroMARK breast biopsy site marker and other devices, an FDA Form 483 states.

A federal court has ordered New Jersey-based Accurate Set to cease operations until its restorative dental products receive FDA approval.

A British cardiac device company earned an FDA warning letter over its failure to establish medical device reporting (MDR) procedures.

Various violations related to cGMPs, including failure to adequately validate packaging and sterilization processes, has landed PhotoMedex — a maker of burn and wound dressings — an FDA warning letter.