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The European Commission (EC) is threatening to take legal action against Italy, Poland, Slovenia and Finland for failing to implement the Falsified Medicines Directive, an EU-wide anti-counterfeit initiative that has been in effect since Jan. 2, 2013. Read More
To satisfy new Australian guidance on supplier qualification for raw materials, drugmakers need to stop using one-size-fits-all questionnaires and adopt screening methods that are specific to the products they are making. Read More
Nevada-based Green Valley Drugs, which recalled all of its sterile compounded products in April, has been warned by the FDA for a lack of sterility assurance and general quality control. Read More
The FDA is maintaining pressure on Pfizer subsidiary Meridian Medical Technologies, a maker of drug auto-injectors, to improve quality at its Missouri plants. Read More
The FDA has hit Wockhardt with a second “import alert,” banning drug products from its Chikalthana plant in western India — the latest in a spate of regulatory actions taken against the struggling drugmaker. Read More
OTC drugmaker AmeriDerm Laboratories has a long history of failing to test its Paterson, N.J., plant’s water supply for objectionable microorganisms, the FDA says. Read More
Sterile injectables maker Hospira was hit with a new Form 483 containing nearly two dozen observations after FDA investigators followed up an October 2012 inspection that uncovered inadequate sanitization procedures at its Irungattukottai, India, manufacturing plant. Read More
The FDA’s unusual demand that an importer of active pharmaceutical ingredients (API) list the distributors that might sell finished product created with the API has sparked a lawsuit that could further complicate U.S. border control processes. Read More