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South Africa’s Medicines Control Council is preparing to implement the country’s first regulatory system for medical devices and in vitro diagnostics. Read More
Morris Innovative received a six-observation Form 483 for its handling of out-of-specification products, internal audits and corrective and preventive action plans. Read More
The FDA handed Zimmer Biomet Holdings a warning letter dated May 27, citing GMP non-conformities at the company’s facility in Montreal, Canada. Read More