The GMP Letter

Failure to report a critical change in a Class III medical device can lead to more than a warning letter and other compliance problems with the FDA.

GE Healthcare’s Integrated IT Solutions division allegedly has inadequate corrective and preventive action (CAPA) procedures for its Centricity Imaging and Picture Archiving and Communication Systems (PACS) software packages, according to an FDA warning letter.

O’Ryan Industries received a warning letter for allegedly distributing its Endo 150 endoscopic light source and Omega ST sterilizer without having procedures for quality system management or medical device reporting (MDR).

The FDA granted approval to St. Jude Medical for a new plant in Arecibo, Puerto Rico, for the manufacture of pacemakers, cardiac leads and implantable cardioverter defibrillators (ICDs).

Swedish firm Cochlear Bone Anchored Solutions has been placed under a U.S. import alert for disagreements with the FDA over the appropriate level of adverse event reporting, according to a recently posted warning letter.

Kimberly-Clark Healthcare failed to obtain marketing clearance before selling 12 models of previously approved sterilization wraps that the FDA considers new products because they were modified with significant changes, a warning letter alleges.

Medtronic booked $94 million in revenue for its Physio-Control implantable defibrillator business during the firm’s fiscal first quarter despite operating under an FDA consent decree.

Schroeder Industries’ alleged failure to follow quality system requirements during the production of brass rounds used for modulation of beam intensity in radiation therapy earned it a warning letter.

Despite expectations that the FDA will lift Boston Scientific’s corporate warning letter, which would clear the way for the company to launch Taxus Liberte, its next-generation drug-eluting stent, an analyst says that will not change the firm’s competitive position in the stent market.

An international effort to develop standards that minimize the risk of life-threatening tubing misconnections is gaining momentum, according to an industry group.

The Global Harmonization Task Force’s (GHTF) Study Group 1 has released its final guidance on classification of in vitro diagnostic (IVD) medical devices.

View the entire supplement in PDF format.

New congressional legislation for track-and-trace drug pedigrees is unnecessary and probably will not move out of a House committee in the near future, according to an executive from the National Association of Chain Drug Stores (NACDS).

The FDA’s Center for Drug Evaluation and Research (CDER) is seeking sponsors to participate in a one-year pilot project for electronic submission and processing of clinical trial data in XML format.

In a move to speed the transition to a national electronic healthcare environment, HHS has proposed regulations to switch to the ICD-10 code set for diagnoses and to adopt the updated X12 standard, Version 5010, for electronic transactions.

The world’s top 20 pharmaceutical companies are completing their transitions from paper case report forms to electronic data capture (EDC) systems for clinical trials, according to an industry leader.