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GMP News

USP Cannabis Monograph

A revised USP HMC Cannabis monograph has been posted in April 2024. In particular, the proposed specifications for the labeled amount of  tetrahydrocannabinol (THC) and cannabidiol (CBD), as well as other cannabinoids were changed.

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FDA Warning Letter - Missing incoming Control Tests

In June 2024, the U.S. FDA issued a Warning Letter to the Portuguese company "Fancystage Unipessoal, LDA" after having inspected its site in January 2024. According to U.S. FDA Warning Letter, the firm failed to do proper incoming control tests to identity the goods.

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Congressional Scrutiny on FDA's Foreign Inspection Program puts Pressure on Agency

"Warning Letters" for FDA: Two recent letters from Congress to the FDA Commissioner highlight ongoing and historical challenges within the FDA's foreign drug inspection program, even raising concerns about inspector competence.

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