The QMN Weekly Bulletin

American Optisurgical, an ophthalmic device company based in Lake Forest, Calif., received a 13-observation Form 483 after an inspection by Irvine, Calif., CDRH staff stretching from Jan. 30 to Feb. 23.

An Indian panel of government health ministers has recommended price controls be applied to all 348 generic drugs on the country’s essential generic drugs list.

Quality system violations at Alere’s San Diego, Calif., manufacturing facility have landed the healthcare management company a warning letter.

The FDA last week released updated guidance describing how it intends to comply with submission review timelines set during user fee negotiations earlier this year.

Ben Venue’s Bedford, Ohio, plant — in the news this past year for quality problems — has restarted a handful of production lines to make some of its critical-need drugs available again.

Qualitest, a subsidiary of Endo Health Solutions, is recalling one lot of its hydrocodone bitartrate and acetaminophen tablets because some may exceed the weight specification and could be super potent.

The FDA plans to issue clarifying guidance to address confusion among devicemakers about what exactly constitutes an enhancement and what qualifies as a recall, an FDA official says.

API makers with manufacturing facilities in Canada can expect nearly $1 million dollars in initial costs and $100,000 in annual compliance and administrative costs related to proposed manufacturing regulations.