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Why The US FDA Did Not Appreciate Valisure’s Extra Measure Of Protection From Poor Quality Drugs

 
• By Bowman Cox

Unusual citations for DSCSA violations in a recent inspection report and untitled letter from the FDA provide insight into the agency's concerns about the pharmacy that second-guesses the regulatory system it oversees by testing drugs before dispensing them.

testing drugs
the fda takes aim at valisure • Source: Shutterstock

Valisure LLC, a pharmacy venture launched in 2015 to protect patients by testing medicine before dispensing it, has come under fire from the US Food and Drug Administration for failing to comply with good manufacturing practices.

A recent untitled letter to the firm sends a clear message: if anyone wants to protect patients from poorly made...

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