Drug GMP Report

The FDA’s work toward tighter supply chain control through international regulatory cooperation is falling short, but a new global strategy may speed up the agency’s progress, a top FDA official says.

The FDA has said enough is enough to McNeil Consumer Healthcare over its repeated manufacturing problems, issuing a consent decree that indefinitely closes one plant and places oversight over two others.

Another Johnson & Johnson (J&J) product is being recalled — the fifth recall in less than a month — amid sterility concerns.

ATHENS, Ga. — Companies that have a track record of non-compliance with GMPs should come under greater FDA scrutiny and be more likely to get inspected, the FDA’s associate commissioner for regulatory affairs has suggested.

The FDA has put a clinical hold on a Phase II trial for RegeneRX Biopharmaceuticals’ investigational drug RGN-352, a formulation of Thymosin beta 4 (TB4) to treat acute myocardial infarction, after discovering deviations from cGMP regulations at the contract manufacturer for the drug.

Workers at McNeil Consumer Healthcare’s troubled Fort Washington, Pa., facility routinely ignored abnormal test results for various products that were later recalled, according to a six-observation Form 483.

An FDA inspection of Pfizer’s Pearl River, N.Y., plant resulted in 22 Form 483 observations.

Manufacturing issues with chronic kidney disease drug Hectorol have resulted in a multi-item Form 483 for Genzyme.

A Washington, D.C., law firm is pushing for the FDA to create a website that will disclose more information on legal enforcement actions.

APP Pharmaceuticals is recalling five lots of the oncologic irinotecan HCl injection after several reports of particulates found in vials.

ATHENS, Ga. — The FDA may begin issuing warning letters to drugmakers when their contracted suppliers fall out of agency compliance, signaling further agency efforts to strengthen the safety of pharmaceutical supply chains.

The FDA will soon begin working more closely with other federal agencies — including Customs and Border Protection (CBP) — as it hopes to nab more counterfeit drugs entering the U.S. drug supply chain.

As Japan continues to deal with the aftermath of a massive 9.0 earthquake and ensuing tsunami, it appears the country’s pharmaceutical industry and U.S. companies with operations there have not suffered extensive damage.

Former KV Pharmaceutical CEO Marc Hermelin has been fined and will do jail time for the distribution of misbranded products, including oversized morphine tablets.

In response to several recalls, the FDA is warning drug manufacturers of the potential formation of glass fragments in injectable drugs filled in small-volume glass vials.

Citing a dramatic spike in thefts of prescription drugs and medical devices, a group of democratic senators March 8 introduced legislation to crack down on medical product heists at every point in the supply chain.

Supplies of Genzyme’s Fabry disease drug Fabrazyme have hit another snag as the company announced further manufacturing problems for a drug already in short supply.

Dakota Laboratories has received a warning letter for significant violations of cGMP regulations and for mislabeling two drugs.

The FDA’s oversight of medical products remains a “high-risk” area for mismanagement, according to a recent update to the GAO’s High-Risk Series, which points to ongoing issues with the agency’s inspection of overseas facilities and postmarket safety monitoring.

The FDA has issued new guidance to help manufacturers decide when separate buildings are necessary to prevent non-penicillin beta-lactam antibiotics from cross-contaminating other pharmaceuticals.

In the wake of a devastating earthquake in Japan, the FDA is urging drugmakers to develop contingency plans to use during emergencies that result in many workers absent from manufacturing plants.

In an effort to bolster the safety and reliability of widely used drugs, the U.S. Pharmacopeia (USP) is partnering with FDA and the Consumer Healthcare Products Association (CHPA) to update quality standards for more than three dozen products.

Pfizer has recalled all lots of its chronic pain medication Embeda due to a defect found during testing, a move that could keep the drug out of pharmacies for months.

As the FDA continues to clamp down on drug supply chains, some companies are concerned that an ill-defined sliver of drug ingredients will drive suppliers to increase costs or reduce supply.

Under a new pilot program, NDAs submitted to the FDA and European Medicines Agency (EMA) with quality by design (QbD) components will undergo parallel review from both regulatory agencies.

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (known jointly as PIC/S) signed a new cooperation agreement with the European Medicines Agency (EMA) to strengthen their cooperation in areas of common interest related to good manufacturing and distribution practice (GMDP).