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Home » Topics » Pharmaceuticals » GMPs

GMPs
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ANSM Says Chinese Drugmaker Falsified GMP Documents

August 10, 2017
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

Chinese Heparin Testing Lab Warned by FDA

August 10, 2017
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

Compounder Ordered to Halt Operations

August 7, 2017
A federal judge has barred an Alabama compounder from manufacturing, holding or distributing drugs until the facility complies with FDA regulations. Read More

ANSM Says Chinese Drugmaker Falsified GMP Documents

August 7, 2017
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

FDA Warns Supplement Companies Over Drug Claims, GMP Violations

August 7, 2017
The FDA continued its crackdown on supplement companies over drug claims and GMP violations, warning companies in New York and Alabama. Read More

Warning Letter Roundup: Five Firms Cited for GMPs, Other Issues

August 7, 2017
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

CFDA Conducted Fewer Foreign Inspections in 2016

August 7, 2017
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

FDA Warns Four Compounders for Lacking Valid, Individual Prescriptions

August 1, 2017
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

Maryland Drugmaker Warned on Sterility

July 31, 2017
The agency said Option Care’s sterility practices are in violation of federal standards and law. Read More

Sterile Drugmaker’s Sterility Procedures Found Lacking

July 28, 2017
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

AbbVie Ordered to Pay $150 Million to AndroGel User for Heart Attack

July 28, 2017
In the first trial verdict of thousands of similar suits, a federal jury ordered AbbVie to pay $150 million to a man who blamed inadequate labeling of its testosterone drug AndroGel for his heart attack. Read More

ANSM Says Chinese Drugmaker Falsified GMP Documents

July 28, 2017
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
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