Drug GMP Report

Congressional leaders can agree on one thing — there is a need for a national drug track-and-trace system.

The California State Board of Pharmacy has reported a possible attempt to introduce counterfeit versions of EMD Serono’s Serostim, an HIV treatment, into the U.S. supply chain.

An FDA official praised a new excipient supplier certification program for drug manufacturers as a way to safeguard supply chain quality and ease the pain of shortages.

Genentech is working to figure out why some vials of blood clot drug Cathflo Activase contain rubber stopper particulates.

FDA Commissioner Margaret Hamburg said the agency needs more money and authority to keep its recent spate of surprise compounding pharmacy inspections going, but GOP House leaders rejected the request during a confrontational committee hearing last month.

Teva has recalled several lots of two of its popular birth control products due to off-color pills.

The method Novartis uses to clear batches at its Suffern, N.Y., facility was deemed inadequate by FDA investigators, resulting in a Form 483.

The FDA found that Hemcare of Oregon’s complaint records lack detail, landing the drug manufacturer a Form 483.

Ranbaxy subsidiary Ohm Laboratories received a Form 483 for quality control lapses surrounding blue glass in the active pharmaceutical ingredient (API) for atrovastatin calcium tablets.

Allergan has received a complete response letter (CRL) for its aerosol-based migraine drug Levadex.

The FDA plans to test a device in Ghana in 2013 and 2014 that it hopes will root out counterfeit and substandard antimalarial drugs.

Just two months after its first commercial sale, Biotest Pharmaceuticals has voluntarily recalled one lot of its immunodeficiency drug Bivigam due to visible particles.

Asada Milling, a Japanese maker of active pharmaceutical ingredients (API), has been warned by the FDA for a general lack of quality control — and cleanliness — at its facility located in Gunma, Japan.