FDA blasts Colom­bian drug man­u­fac­tur­er in warn­ing let­ter for not prop­er­ly ad­dress­ing API flaws

When the FDA calls the qual­i­ty of a drug­mak­er’s prod­ucts in­to ques­tion, the worst pos­si­ble re­sponse is “we can’t prove what we make is up …

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