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OTC drugmaker Almil Nutritional Products has been issued an FDA warning letter outlining 12 good manufacturing practice (GMP) deficiencies found by investigators during an inspection of its Brea, Calif., manufacturing facility.
The FDA is calling for a regulatory meeting with Respironics to determine why the Carlsbad, Calif.-based manufacturer repeatedly failed to submit medical device reports (MDRs) in connection with defective check valves on its Espirit ventilator.
Utah Medical Products (UTMP) has filed a lawsuit against the FDA to prevent the agency from conducting wasteful inspections at its Medvale, Utah, manufacturing plant.
The FDA has shut down four websites it claims sold bogus transdermal contraceptive patches containing no active ingredients, as part of its ongoing enforcement efforts against drug counterfeiters, the agency said Thursday.
The FDA has issued a warning letter to Xttrium Laboratories for failing to correct problems with its postmarketing adverse drug experience (PADE) reporting system for chlorhexidine gluconate products.
Devicemakers that act as sponsors during clinical trials need to be careful that the investigators selected to conduct the trials have appropriate training and experience to use the device being tested.
Various neonatal chemistry systems and Immunoisoelectric focusing diagnostic kits manufactured by PerkinElmer Life Sciences were seized last week after the FDA repeatedly warned the company to correct numerous quality system violations at its Norton, Ohio facility where the products are manufactured.
The FDA is continuing its battle to stop the illegal importation of prescription drugs from Canada, issuing a warning letter Jan. 22 to a pharmacy benefits manager (PBM), insurance company and claims processor. PBM Expedite-Rx, claims processor SPC Global Technologies and insurer Employer Health Options were accused by the agency of “facilitating illegal imports of [Rx] drugs from Canada and misleading the public about the drugs’ safety.”
The FDA continued its battle to stop the illegal importation of prescription drugs from Canada yesterday, issuing a warning letter to a pharmacy benefits manager, insurance company and claims processor.
Print and television ads for Aventis Pharmaceuticals’ leading allergy product made unsubstantiated superiority claims to other prescription remedies on the market, according to an untitled letter released by the FDA, which caused the firm to pull the ads in response, Aventis announced Jan. 14.