The Food and Drug Administration described “significant violations of current good manufacturing practice” in a warning letter to a Pfizer unit that manufactures Mylan’s EpiPen allergic reaction treatment. The unit, Meridian Medical Technologies Inc., “failed to thoroughly investigate multiple serious component and product failures… including failures associated with patient deaths and severe illness,” the warning letter said, referring to an FDA inspection of a Missouri manufacturing facility between February and March of this year. “You also failed to expand the scope of your investigations into these serious and life-threatening failures or take appropriate corrective actions, until FDA’s inspection.” The regulator asked the company to review its manufacturing investigations and provide its plan for addressing safety risks, all within 15 days. If the company doesn’t promptly fix the violations, there may be legal action, and the FDA may not approve applications listing the manufacturing facility, the FDA said. Mylan shares declined nearly 1% in moderate Thursday afternoon trade, while Pfizer shares rose a scant 0.3% in heavy trade, compared with a 0.1% decline in the S&P 500
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