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The FDA cited API manufacturer Syrmise of Holzminden, Germany, for eight violations including failure to investigate when a component, intermediate or API did not meet specifications. Read More
Australia’s drug regulatory agency is urging drugmakers to reassess their quality control and data management systems after agency officials found frequent data integrity violations during GMP inspections over the past five years. Read More
GMP woes for foreign and domestic facilities continued as the FDA issued three warning letters to Indian and Chinese factories as well as a U.S. facility over data integrity and quality control problems. Read More
Divi’s Laboratories has been warned by the FDA for failing to meet current good manufacturing practice requirements, adding to the Indian drug manufacturer’s compliance woes. Read More