MADISON, N.J. - Wyeth said Tuesday that the U.S. Food and Drug Administration’s (FDA) San Juan District Office informed the company that a re-inspection of the Guayama, Puerto Rico manufacturing facility resulted in a positive re-classification.
The re-classification indicates that any issues the FDA previously had with the facility have been corrected or do not require further regulatory action.
“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,” said Bernard Poussot, President, COO and Vice Chairman at Wyeth. “We are committed to maintaining the highest standards of quality and compliance in our manufacturing operations around the world.”
In May 2006, the company received a warning letter from the FDA about several specific concerns about manufacturing at Guayama.
Wyeth is a research-driven pharmaceutical and health care products company. It develops, manufactures and markets pharmaceuticals, vaccines, biotechnology products and non-prescription medicines.
