Wyeth received an FDA warning letter in May 2006 that raised several specific concerns about manufacturing at the facility.
Based on the nature of the inspection observations issued by the FDA, Wyeth said it is hopeful that it can respond to the remaining concerns and that the agency will be able to determine that the safety issues have been satisfactorily resolved.
Wyeth intends to respond to the observations issued by the FDA inspector no later than mid-April and then will seek to continue its discussions with the agency regarding the overall compliance status of the facility.
The Guayama facility also underwent a current Good Manufacturing Practices (cGMP) inspection by representatives of the European Medicines Agency in March. Wyeth said the inspection was concluded successfully with no critical or major observations.