FDA Re-inspection Results in Positive Re-classification of Guayama Facility
Madison, N.J.,– Wyeth (NYSE: WYE) today announced that the U.S. Food and Drug Administration’s (FDA) San Juan District Office has informed the Company that the recent FDA re-inspection of its Guayama, Puerto Rico manufacturing facility has resulted in a positive re-classification of the site. The new classification means that any issues found by the FDA have either been corrected by the Company or do not merit any further regulatory action. Guayama will continue to serve as a strategic manufacturing site and a source for future Wyeth products.
“We are pleased that FDA has re-classified the Guayama facility and we were able to resolve its concerns in a satisfactory manner. The change in status allows for the timely approval of new products manufactured at the site,” says Bernard Poussot, President, Chief Operating Officer and Vice Chairman, Wyeth. “We are committed to maintaining the highest standards of quality and compliance in our manufacturing operations around the world.”
This re-inspection was related to the Warning Letter FDA sent to Wyeth in May 2006 regarding several specific concerns about manufacturing at Guayama.
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