The QMN Weekly Bulletin

Alexion is reviewing its analytical methodologies and procedures to ensure its risk assessments meet the FDA’s expectations, the drugmaker said.

The prospect of a standardized single audit program for medical devices, currently being developed by the International Medical Device Regulators Forum, is fueling efforts by Brazil’s Anvisa to bring device good manufacturing practice regulations in line with international standards, an expert says.

Cardinal Health, which manufactures positron emission topography (PET) drugs at a Tampa, Fla. plant, received a Form 483 for thin investigations into batch failures.

Edwards’ Draper, Utah, facility received a lengthy warning letter related to the company’s cardiac surgery systems products, with observations on design and process validation, CAPAs, finished device acceptance and packaging.

China and India are working to help local manufacturers of active pharmaceutical ingredients satisfy the tough, new quality requirements in the EU’s Falsified Medicines Directive.

Problems handling mold and defects at two plants sparked an FDA request for Baxter International to take a hard look at its global manufacturing operations.

Industry will get much of what it asked for in the unique device identifier final rule, which is expected to be released around its June 19 deadline.

A Form 483 posted by the FDA May 29 highlights the quality deficiencies that led agency reviewers to reject Gilead Science’s applications for a pair of HIV treatments.