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Theqmnweeklybulletin

Oct. 26, 2012

Vol. 4 No. 43

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Ophthalmic Company Gets Form 483 on Procedure, Validation Issues

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. Read More

Indian Health Ministers Would Impose Price Controls on All ‘Essential’ Generic Drugs

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. Read More

Alere Slapped With Warning Letter for Range of Quality System Issues

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

FDA Details Time Clock Strategies for PMAs, 510(k)s in Draft Guidance

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. Read More

Ben Venue’s Bedford Plant Resumes Producing Some Generic Injectables

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. Read More

Qualitest Recalls Pain Drug Tablets on Oversize Concerns

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. Read More

FDA Plans Guidance on Device Enhancement versus Recall

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. Read More

Health Canada Expects Minimal Manufacturer Costs From New GMP Requirements for APIs

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. Read More