The problems persist at its Guayama, Puerto Rico, manufacturing facility. The drugmaker just issued a statement that the latest FDA inspection will take “at least several more weeks to complete.”

But Wyeth blamed “FDA internal scheduling and work plans” for the latest delay, without saying whether violations persist. The FDA review began in January and follow a May 2006 warning letter. The company has had numerous run-ins with the FDA over several plants, one of which operates under a consent decree, and the problems in Puerto Rico are forcing the introduction of new drugs.

There may be more later after Wyeth execs hold a 5 pm EST conference call.

Separately, Wyeth reaffirmed its 2007 full year earnings guidance of $3.40 to $3.50, an increase of 8 percent to 11 percent over last year,and added that diluted earnings for the first quarter should exceed the current First Call mean analyst estimate of 85 cents.

Finally, the drugmaker disclosed that about 5,200 Prempro lawsuits have been filed on behalf of about 8,400 women. Approximately 60 percent were filed in federal courts and the rest are in various state courts.

[tags]FDA, Manufacturing, Prempro, Puerto Rico, Wyeth[/tags]