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The FDA warned another compounding pharmacy for mixing unapproved drugs and for poor quality, with Pharmacy Creations becoming the latest compounder to challenge agency enforcement of its activities. Read More
The FDA chided positron emission tomography (PET) drug manufacturer IBA Molecular North America for not properly handling complaints and quality production. Read More
GlaxoSmithKline’s vaccine plant in Canada received an FDA warning for a bevy of quality violations such as failing to prevent contamination in its manufacturing processes and water system. Read More
GlaxoSmithKline’s vaccine plant in Canada received an FDA warning for a bevy of quality violations such as failing to prevent contamination in its manufacturing processes and water system. Read More
Indian drugmaker Cadila Healthcare is recalling more than 10,000 bottles of antihistamine due to a drug mix-up, becoming the latest Indian company to face quality problems. Read More
Canadian generics maker Apotex’s plant in Bangalore, India, has rampant problems with data manipulation, including continuously retesting batches until the desired result is achieved, the FDA charged in a warning letter. Read More
Canadian generics maker Apotex’s plant in Bangalore, India, has rampant problems with data manipulation, including continuously retesting batches until the desired result is achieved, the FDA charged in a warning letter. Read More
SAN DIEGO — The FDA expects to start collecting manufacturing quality metrics data from drugmakers sometime in 2015, a move that agency officials say will cost manufacturers a small amount but will pay off in the potential for fewer inspections. Read More
Regulators pushing for greater international cooperation cautioned that relying on other countries’ inspections would require overcoming crucial hurdles such as incompatible technology, language barriers and keeping trade secrets secret. And they urged drugmakers to step up their involvement. Read More
Inspections at beleaguered Indian generics firm Wockhardt’s Illinois plant found quality control issues ranging from poor cleanliness to shoddy product testing and incomplete record-keeping, the FDA said. Read More