Wyeth on May 10 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 reclassification 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 the FDA has reclassified 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 that the FDA sent to Wyeth in May 2006 regarding several specific concerns about manufacturing at Guayama.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines. The company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
