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Gilead SEC filing confirms FDA warning letter on GMP concerns

 
• By Nancy Faigen

Gilead Sciences has stated in a US Securities and Exchange Commission filing that it has received a warning letter from the FDA concerning good manufacturing practice (GMP) deficiencies at its San Dimas, California, facility. Until the firm is able to correct the outstanding issues, Gilead says that it may be forced to curtail exports of its antifungal treatment AmBisome (amphotericin B).

Gilead Sciences has stated in a US Securities and Exchange Commission filing that it has received a warning letter from the FDA concerning good manufacturing practice (GMP) deficiencies at its San Dimas, California, facility. Until the firm is able to correct the outstanding issues, Gilead says that it may be forced to curtail exports of its antifungal treatment AmBisome (amphotericin B).

The letter has not yet been posted on the FDA's website. However, according to Gilead it details inadequacies identified by...

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