France’s Agency for the Safety of Health Products cited Chinese API manufacturer Chongqing Succeway Pharmaceutical for GMP non-compliance, including one critical finding: active tampering with company data. 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

A federal judge has barred an Alabama compounder from manufacturing, holding or distributing drugs until the facility complies with FDA regulations. Read More

France’s Agency for the Safety of Health Products cited Chinese API manufacturer Chongqing Succeway Pharmaceutical for GMP non-compliance, including one critical finding — active tampering with company data. Read More

The FDA continued its crackdown on supplement companies over drug claims and GMP violations, warning companies in New York and Alabama. Read More

The FDA issued a slew of warning letters this month to a wide range of sources, from traditional drugmakers to supplement companies, for GMP violations ranging from insufficient sterility practices to metal embedded in pills. Read More

China’s Food and Drug Administration only carried out a fraction of the dozens of planned GMP inspections of foreign sites last year. Read More

The FDA sent warning letters to four compounding pharmacies, reminding them of their obligations under federal law to compound drug products based on valid prescriptions, while one compounder told the agency it was exempt from the FDA’s GMP requirements. Read More

The FDA found substantial sterility problems on a visit to Kansas-based ARJ Infusion Services, makers of in-home intravenous medications for adults and children with rare and chronic conditions. Read More