The inspection of the site began in late January 2007 and is related to an FDA Warning Letter received in May 2006 that raised several specific concerns about manufacturing at the Guayama facility. Production at the plant has been reduced as a result of the inspection.
As previously noted, Wyeth has undertaken a corrective action plan to improve compliance at the plant which manufactures birth control pills, hormone replacement drugs, antidepressants and over-the-counter pain relievers.
Wyeth also reaffirmed its 2007 full year pro forma diluted earnings per share guidance of $3.40 to $3.50, an increase of 8% to 11% over 2006.