The QMN Weekly Bulletin

Heeding drug industry feedback, the European Medicines Agency (EMA) is reducing the amount of information collected from companies under provisions of the 2010 pharmacovigilance law.

FDA investigators found fault with Canada-based Intelligent Hospital Systems’ (HIS) failure to establish a plan defining quality practices, resources and activities relevant to its devices and its failure to spell out how quality requirements will be met, according to a recent warning letter.

As global pharmaceutical trade grows, the FDA’s model of surveillance needs revamping, including placing the burden on the drug industry to prove a product is safe before it enters the U.S., an FDA official says.

The FDA has handed telemetry maker ScottCare a warning letter for a host of GMP violations at its Cleveland, Ohio, plant, including improper implementation of corrective and preventive action (CAPA) procedures.

Swiss devicemaker Synthes faces trouble from two sides, with an FDA warning letter posted just days after the company was sued by the families of two patients who died on the operating table during illegal clinical trials.

The FDA wants Warner Chilcott’s Fajardo, Puerto Rico, plant to do a retrospective review of its stability program for all approved products on concerns that some may not meet specifications throughout their shelf life, according to a recent warning letter.

A British cardiac device company earned an FDA warning letter over its failure to establish medical device reporting (MDR) procedures.

APP Pharmaceuticals received a warning letter for persistent media fill failures and recurring critters in manufacturing areas of the company’s Grand Island, N.Y., plant.