The QMN Weekly Bulletin

In many countries, independent experts help make approval decisions on YOUR products.

Troubled sterile injectable maker Ben Venue Laboratories is extending its voluntary manufacturing pause as major reconstruction in one wing of its now shuttered Bedford, Ohio, plant will take nine months to complete.

Reducing costs in tough economic times is tempting, but drug and device manufacturers should not cut corners when it comes to process validation — especially after release of the FDA’s final process validation guidance, experts advise.

Device-related adverse events are increasing in the EU, with the most recent numbers showing a 13 percent rise in the UK to 10,280 in 2010.

Pfizer is voluntarily recalling 14 lots of its oral contraceptive Lo/Ovral-28 and 14 lots of the norgestrel and ethinyl estradiol generic product as some blister packs may be missing tablets or displaying tablets out of sequence.

RI Consultants, a maker of radiotherapy devices, was handed a Form 483 for a dearth of device history records and for not identifying the training needs of personnel at its Nashua, N.H., plant.

Drugmakers befuddled by manufacturing failures, such as product contamination by microorganisms, are urged to perform risk assessments and take preventive action, the FDA says.

Online claims that overstated the medical benefits of infrared lasers for home use landed three devicemakers in hot water with the FDA.