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Theqmnweeklybulletin

Oct. 5, 2012

Vol. 4 No. 40

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Public Citizen Presses FDA for Boxed Warning on Top-Selling Hypertension Drugs

Public Citizen is urging the FDA to require boxed warnings on the labels of many top-selling hypertension drugs, including angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) and Novartis’ aliskiren, to warn against their use in combination. Read More

FDA Documents, Statements Prioritize the ‘P’ in CAPA: Expert

An effective corrective and preventive action (CAPA) program will prioritize prevention and continuity in process improvement — primarily by linking to manufacturing systems beyond those concerned with deviation management and failure investigations, compliance experts say. Read More

EU Device Regulation Includes Premarket Scrutiny Mechanism, Industry Vows Pushback

As widely anticipated in the wake of the PIP breast implant and metal-on-metal hip scandals, the European Commission is proposing that high-risk medical devices undergo more rigorous premarket scrutiny, but not on the level required by the U.S. Food and Drug Administration (FDA). Read More

St. Jude Malaysia 483 Cites Cleanroom, Training Concerns

St. Jude Medical’s Penang, Malaysia, plant received a seven-observation Form 483 at the conclusion of a May 2011 CDRH inspection. Read More

Global Dragnet Nabs $10.5 Million in Online Counterfeit, Unapproved Drugs

An international offensive against thousands of online peddlers of counterfeit and illicit drugs has resulted in the seizure of some 3.75 million units with an estimated value of $10.5 million. Read More

Expert Questions Recall Numbers, Advises Better Testing Procedures

Reports of a 24 percent increase in recalls caused by medtech software may not accurately reflect the scope of the problem or what it means for suppliers, an expert says. Read More

Novartis Asks Employees to Take ‘Personal Responsibility’ for Quality

Novartis is launching an in-house campaign to underscore employees’ “personal responsibility” for quality as the company’s manufacturing remediation continues. Read More

Failure to Report Adverse Events Behind California Company’s 483

Riverside, Calif.-based Pacific Consolidated Industries (PCI) received a nine-count Form 483 after inspectors from the Irvine, Calif., CDRH office found deviations in the company’s complaint and adverse event handling activities. Read More