It took longer than the drugmaker hoped, but the FDA has finally given its blessing to the troubled manufacturing facility in Guayama. In a brief statement, Wyeth says the agency issued a “positive re-classification.” According to the company, this means that any issues found by the FDA have either been corrected or do not merit any further regulatory action. The FDA issued a warning letter last May about ongoing problems at the plant.

“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, Wyeth’s vice chair and coo. “We are committed to maintaining the highest standards of quality and compliance in our manufacturing operations around the world.”

Indeed, this is good news for Wyeth, which was forced to delay product introductions while the agency conducted its inspections. The real issue, however, is whether Wyeth overhauls its manufacturing. The drugmaker has had numerous run-ins with the FDA over several plants, one of which operates under a consent decree. Yet serious infractions continued to occur.

Could this really be the end?

Wyeth’s statement.
[tags]Puerto Rico, Wyeth[/tags]