The GMP Letter

The FDA has been spared from having to stop working because of a feared federal government shutdown now that President Barack Obama has signed a measure temporarily funding the agency and other federal programs through March 18.

CDRH plans to introduce this year a prototype for a new adverse event database to replace its Manufacturer and User Facility Device Experience Database (MAUDE).

Swedish devicemaker Cenova has been warned for violations in its handling of nonconforming product.

The FDA has approved Medtronic’s Revo as the first pacemaker designed for use during certain magnetic resonance imaging (MRI) exams.

Tyco Healthcare Canada’s handling of issues cited in supplier corrective action reports (SCARs), such as particles found in syringes, led to a warning letter for the company’s Montreal facility.

The European Commission’s (EC) formal objection to 11 international medical device standards may not mean the harmonizing guidelines are rife with problems, but instead signal the system is evolving to become more international instead of focusing on European requirements.

Zoll Circulation, a maker of an automated chest compressor used to assist CPR, failed to notify the FDA of several complaints and product failures, the agency found during an inspection at its Sunnyvale, Calif., facility.

The FDA has informed San Diego-based CareFusion that it needed to include additional information in a report following a patient death, according to an Oct. 8 Form 483.

International Immuno-Diagnostics of Foster City, Calif. has received a Form 483 despite attempting to correct four of five observations from a previous May 2010 inspection.

An FDA inspection of Tra & Accessories found failures in its control of design, purchasing and the warehouse environment for products, resulting in a warning letter.

Swiss pharmaceutical giant Roche is recalling an insulin delivery system following concerns it could deliver the wrong dose to consumers.

The FDA has warned Coastal Implant Technologies for manufacturing violations although the company claims it is the distributor, and not the manufacturer, of two endosseous dental implants.

Quality problems with metal-on-metal (MoM) hip replacement systems, like Johnson & Johnson (J&J)’s ASR devices, may not be as widespread as UK data indicates, the FDA says.

The FDA has down-classified medical device data systems (MDDS) from Class III into Class I via a final rule, which could help manufacturers compete with IT companies in this area.

The FDA is requesting postmarket studies of temporomandibular joint (TMJ) implants after a substantial number of patients had the implants replaced within three years or less because of extreme pain.

Lynn Peavey, a manufacturer of sexual assault evidence and blood alcohol collection kits, has received a GMP warning for several issues, such as lack of procedures for incoming product inspections and lack of verification activities.

Devicemakers responding to Form 483s frequently make common mistakes, such as failing to acknowledge repeat observations or take a global view for corrections — errors that can increase FDA scrutiny, an expert says.