Drug GMP Report

The FDA is bolstering the heparin supply chain with a draft guidance telling drugmakers to test each incoming shipment of heparin for species origin and contaminants, and audit each of their heparin manufacturers and handlers.

While a company-imposed quality control overhaul at Hospira’s Rocky Mount, N.C., facility has assembly lines humming again, production at the plant is not expected to reach full capacity in the near-term and shortages of numerous injectable drugs are likely to continue, Hospira says.

Johnson & Johnson (J&J) subsidiary McNeil Consumer Healthcare is recalling some 574,000 bottles of Tylenol for infants on consumer complaints that its dosing system is a dud.

Johnson & Johnson’s (J&J) upcoming CEO switch, from Bill Weldon to its devices business head Alex Gorsky, could signal the company’s confidence in its ongoing relaunch of McNeil consumer products, an analyst says.

The FDA is asking Merck KGaA for a comprehensive global manufacturing assessment in all of its facilities after inspections at three plants uncovered multiple quality violations, including some that were present at all three sites.

GlaxoSmithKline has recalled 10 lots — some 394,000 bottles — of its hypertension drug DynaCirc CR after quality and commingling issues at Novartis’ troubled Lincoln, Neb., plant, where it was produced.

Components used to make Biogen Idec’s multiple sclerosis drug Avonex were not consistently shown to be suitable for use, drawing a Form 483 for the company’s North Carolina plant.

Horizon Pharmaceuticals’ West Palm Beach, Fla., plant lacks procedures to validate production processes that may cause variability of in-process and finished drugs, the FDA says.

The quality control unit at Warner Chilcott’s Fajardo, Puerto Rico, plant, failed to provide an accurate assessment of distributed drug products with out-of-specification (OOS) results, a Form 483 states.

Nearly all of the slight increase in funding President Barack Obama is requesting for the FDA in his fiscal 2013 budget would pay for additional China-based inspectors and greatly enhance agency presence in the country to protect the supply chain.

The FDA has informed Impax Laboratories that it is satisfied with the company’s efforts to address manufacturing violations at its Hayward, Calif., facility, but the agency has not closed out on the matter because a final, required re-inspection of the plant has yet to occur, Impax says.

ORLANDO — Generic-drug makers need to correct manufacturing quality issues that are the main culprit behind drug shortages or face eroding consumer confidence in their copycat drugs, FDA Commissioner Margaret Hamburg says.

Roche may face shortages of its anemia treatment Mircera and weight-loss drug Xenical after discovering GMP shortfalls at its Florence, S.C., plant.

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.

Counterfeit versions of Genentech’s cancer drug Avastin are circulating in the U.S. supply chain after 19 practitioners bought the drug from an unauthorized foreign supplier, the FDA and the Swiss-owned drugmaker warn.

Ongoing efforts to right GMP wrongs at Bedford Laboratories’ troubled Bedford, Ohio, plant have uncovered fresh manufacturing concerns that recently prompted three drug recalls — two for Ben Venue-marketed products and one for an injectable it produces under contract to Genzyme.