We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
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
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
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
Sterility concerns and other deficiencies at a Maryland drugmaker could be putting patients at risk, the FDA told Option Care Enterprises in Columbia, Md. in a July 20 warning letter. 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