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 site visit. Source: Drug GMP…

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. Source: Drug…

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. Source: Drug…

The European Medicines Agency updated its guidelines for postmarketing variations, safety studies and quality changes. Source: Drug GMP Report

The FDA continued its crackdown on supplement companies over drug claims and GMP violations, warning companies in New York and Alabama. Source: Drug GMP Report

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…