Drug companies must ensure their products meet federal standards for child-resistant packaging before labeling the packaging as child-resistant, the FDA said in draft guidance issued Aug. 2. Source: Drug GMP…
More than 120 questions and answers were added to the European Medicines Agency’s FAQs on the launch of the new EudraVigilance reporting system, set to go live Nov. 22. Source:…
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…
Bangalore-based pharmaceutical company Strides Sashun, formerly known as Strides Arcolab, was recently cited by the FDA for quality problems with pills bound for U.S. markets. Source: Drug GMP Report
Teva is expected to close its facility outside Budapest, Hungary, following a string of quality control problems and major recalls. Source: Drug GMP Report