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A complaint about ineffective erectile dysfunction drugs led to an FDA inspection of a Texas-based compounder, resulting in a lengthy warning letter from the agency detailing sterility concerns. Read More
A PET finished dose manufacturer in Ohio was cited by the FDA after investigators witnessed numerous cGMP violations and potential quality problems on a January 2014 site visit. Read More
FDA investigators visiting a Vista Pharmaceuticals plant in Nalgonda, India found equipment used to manufacture drugs riddled with holes and corrosion, according to a warning letter issued July 5. Read More
A complaint about ineffective erectile dysfunction drugs led to an FDA inspection of a Texas-based compounder, resulting in a lengthy warning letter from the agency detailing sterility concerns. Read More
A Chinese heparin contract testing lab has been warned by the FDA for significant cGMP violations, recalling unresolved questions and concerns from the Chinese heparin scandal a decade ago. Read More
Unable to resolve persistent manufacturing problems, New Jersey-based drugmaker Pacira Pharmaceuticals is ending production of its DepoCyt chemotherapy drug and closing the California plant where it is made. Read More
Drugs labeled as sterile were exposed to unsanitary conditions and may have been contaminated with filth and may be harmful if given to patients. Read More
A federal judge has barred an Alabama compounder from manufacturing, holding or distributing drugs until the facility complies with FDA regulations. Read More