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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
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
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
During a January 2017 inspection, Shandong Analysis and Test Center was found to have failed to ensure its API testing procedures were scientifically sound. 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
Three unapproved ingredients and a host of labeling and other GMP violations have resulted in an FDA warning letter for a Texas-based supplement company. Read More
Three unapproved ingredients and a host of labeling and other GMP violations have resulted in an FDA warning letter for a Texas-based supplement company. Read More
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