The QMN Weekly Bulletin

A Florida surgical lamp company recently received a warning letter citing a variety of GMP violations.

Flawed standard operating procedures (SOP) at West-Ward Pharmaceuticals were a contributing cause for significant variability in the thickness and hardness of in-process and finished drugs, some of which may have been released, according to a recent warning letter.

Last Year, Gilead acquired GS-7977, a nucleotide analog polymerase inhibitor, in its $11 billion purchase of Pharmasset.

Novartis’ cancer drug Gleevec recently got FDA approval for adjuvant use in adult stomach cancer patients along with a label update recommending extended treatment.

Three months after the FDA flagged three manufacturing plants operated by Sandoz for quality control issues, the Novartis subsidiary has temporarily suspended production of certain generic drugs and discontinued some products at its Boucherville, Quebec, facility to address the agency’s concerns.

Addison, Ill.-based Anchor Products received a Form 483 with repeat observations on medical device reporting (MDR) procedures and handling of customer complaints.

Lpath is suspending dosing in two trials of its eye drug iSONEP after learning of compliance issues at its fill/finish contractor Formatech.

Ben Venue subsidiary Bedford Laboratories is voluntarily recalling one lot of its overdose drug acetylcysteine solution USP after finding a single glass particle in a 30 mL vial, the FDA says.