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Theqmnweeklybulletin

May 25, 2012

Vol. 4 No. 21

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FDA Increasing Role in Quality Promotion for Devicemakers, CDRH Official Says

CDRH officials plan a series of public forums in 2012 to gather data to develop an implementation plan for the center’s Case for Quality Initiative — which aims to create an ongoing culture of quality at medical device manufacturers. Read More

Big or Small, FDA Wants to Hear About All Trial-Related AEs

Trial sponsors should notify the FDA about all adverse events brought to their attention by data monitoring committees (DMC), regardless of whether the safety issue is “serious” or not, according to an agency guidance. Read More

European Parliament Calls for Premarket Authorization System in Wake of PIP

As fallout from the defective PIP breast implant imbroglio continues, a European Parliament health committee is calling for tough new regulatory controls, including the creation of a premarket authorization system for certain categories of medical devices — an idea that brought immediate kickback from industry. Read More

Inconsistent CAPA Lands ALK-Abello a Form 483

Corrective and preventive action (CAPA) procedures used to address equipment failures during batch tests at ALK-Abello’s flagship facility are inconsistently applied, an FDA Form 483 states. Read More

UK Devicemaker Warned by FDA on Documentation, Production

Amplivox, a UK subsidiary of Danish company William Demant, received a warning letter from the FDA following a December inspection of its Oxford manufacturing plant. Read More

Pfizer Recalls Odiferous OTC Headache Meds

Pfizer is recalling more than half a million bottles of OTC headache drug Advil Liqui-Gels after customers complained of strong product odors and mildly troubled tummies, the drugmaker says. Read More

Diamond Wipes Gets 483 for Ignoring Quality Control Unit

A project manager at Diamond Wipes’ Chino, Calif., facility bypassed its quality control unit and allowed products deemed unfit for release to be shipped for sale anyway, a Form 483 states. Read More

Device Classification Stand Off With Software Developer Warrants Warning

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. Read More