Drug GMP Report

The FDA is working on a revision to GMP regulations that would require pharmaceutical companies to audit raw material suppliers, a former FDA official says.

Although FDA Commissioner Margaret Hamburg predicted last year that regulated companies that get warning letters would really want a closeout letter, the problem is most of them aren’t getting them.

Genzyme has completed the move of its U.S.-product fill/finish operations from its troubled Allston, Mass., plant as required under an FDA consent decree.

Johnson & Johnson (J&J) subsidiary McNeil Consumer Healthcare is recalling three Tylenol liquid products, 12 Mylanta liquid products and one AlternaGEL liquid product due to a labeling issue discovered during an ongoing review of its quality systems.

Sandoz is voluntarily recalling its 50-mg/2-mL and 250-mg/10-mL methotrexate injections after finding small glass flakes in some vials in four lots.

A quality unit at a McNeil Healthcare manufacturing facility in Puerto Rico has repeatedly failed to follow written and approved procedures, according to a recent Form 483.

Hospira has received a Form 483 for investigation and control failures at a Rocky Mount, N.C., facility.

Baxter Pharmaceuticals Solutions was handed a Form 483 when FDA investigators found investigation failures after it used a syringe lot that was on quality assurance hold during filling activities.

Recent FDA warnings that it will hold pharma executives accountable for companies’ violations signify “somewhat of a change in philosophy,” for the agency as it works to identify and publicize industry-wide quality issues sooner, an FDA official says.

Pfizer is recalling two additional lots of Lipitor — the company’s third recall since August — after two customer reports of an uncharacteristic smell from the drug’s packaging.

B. Braun Medical has announced a nationwide recall of seven lots of heparin, after its supplier — who has been cited by the FDA for similar violations — notified them of potential contamination.

Manufacturers that disagree with inspection observations should make sure they bring it up before an investigator walks out the door, a former FDA official says.

Johnson & Johnson (J&J) subsidiary Janssen-Cilag and Takeda subsidiary Millennium Pharmaceuticals are recalling 395,000 vials of their cancer drug Velcade after five reports of small, white polyester particles in the product.

CP Pharmaceuticals has received an FDA warning letter raising objections to its aseptic conditions and environmental controls.

The FDA is on track to complete most of its risk communication goals for this year, and more updates are on the way for its recall template and recall photos.

Claris Lifesciences has received an FDA warning letter citing investigation failures after metronidazole injection IV bags were found to be contaminated with a swirling mass identified as a fungus.

Drugmakers and distributors should not store drug products, components or packaging materials near wood or wood-derived storage materials unless they know the material has not been treated with a preservative known to emit a moldy or musty odor that can pervade medicine bottles, the FDA says.

Contract manufacturer Nexgen Pharma has received an FDA warning letter citing several significant cGMP violations for finished pharmaceuticals, including issues with its cleaning and testing processes.

A House committee is questioning the FDA’s ability to oversee drugmakers’ Puerto Rico facilities after recent recalls of McNeil OTC products and GMP problems at several companies.