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Two domestic manufacturers and one in the territory of Puerto Rico have been called out by the FDA over inspection findings covering a diverse array of GMP concerns. Read More
The data integrity issues most likely to lead to a delay in FDA marketing approval for new drugs include poor quality control for data entry, systemic errors at clinical study sites — such as enrolling ineligible patients — and database changes made after an initial database lock and study unblinding. Read More
British authorities are ordering an Indian manufacturer to recall batches of progesterone injections after an inspection turned up one critical GMP violation and three major ones at one of its facilities. Read More
British authorities are ordering a U.S. manufacturer to recall drug batches, suspend clinical trials and cease distribution after an inspection uncovered critical GMP violations. Read More