The QMN Weekly Bulletin

Concerns about inadequate drug storage and quality training at Alexza’s Mountain View, Calif., facility were cited by FDA investigators just weeks before the company received a complete response letter (CRL) rejecting its combination product for agitation drug Adasuve, an FDA Form 483 states.

Drugmakers should have a structured and recognized methodology for assessing evidence in an adverse reaction report, taking into account such factors as clinical relevance, quantitative strength of the association and the exposure-response association, according to a draft European Medicines Agency (EMA) guideline.

Implementing a new labeling requirement by the EU’s Central Management Committee (CMC) on Medical Devices will raise devicemakers’ costs without any benefit to patient safety, industry association Eucomed says.

Contract Pharmacal has received a closeout letter, resolving a 2010 warning letter that advised it to hire a good manufacturing practice (GMP) consultant.

Johnson & Johnson (J&J) subsidiary McNeil received an FDA warning letter on a variety of violations related to personal lubricants, feminine hygiene products and other consumer goods.

Lax documentation of testing failures and inadequate design history files for Novalung’s surgical Lung Assist device has resulted in an FDA warning letter for the German company.

Genentech may need to tune up manufacturing practices at a San Francisco, Calif., plant that makes cancer drug Avastin.

China’s State Food and Drug Administration (SFDA) instructed local regulatory authorities to shut down drug facilities manufacturing gelatin capsules contaminated with toxic levels of chromium.