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Injectables maker Hospira is facing yet another recall after a customer found particulates embedded in a vial of 0.5 percent Marcaine painkiller. Read More
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 Tuesday released two major guidances for compounding pharmacies. One establishes for the first time an interim GMP framework for large compounders that register with the agency as outsourced facilities. The second finalizes draft enforcement guidance spelling out what enforcement smaller, traditional compounders can expect from the agency. 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
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
Tianjin Zhongan Pharmaceutical’s manufacturing facility in China failed to follow cleaning procedures and maintain records on equipment operations, according to an FDA warning letter that cites various current good manufacturing practice (cGMP) violations. Read More
Injectables maker Hospira is facing yet another recall after a customer found particulates embedded in a vial of 0.5 percent Marcaine painkiller. Read More
The FDA has issued a warning letter to Mexican biologics maker Instituto Bioclon for significant GMP deviations including failures to ensure adequate environmental monitoring and employee training.
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Unsanitary lab coats, hairnets and facemasks were among the problems cited in a warning letter to compounding pharmacy Medaus, the latest compounder to receive a warning from the FDA. Read More