In Brief: Wyeth-Ayerst Mepergan Fortis

Wyeth-Ayerst Mepergan Fortis: FDA warning letter dated Jan. 16 cites failures "to adequately validate the manufacturing process" and "to properly qualify" a filler used on a packaging line for meperidine/promethazine capsules based on a November inspection. Wyeth's Dec. 23 response "is inadequate because it states additional lots...will be manufactured prior to conducting manufacturing process validation," FDA said. "Your response does not indicate the steps to be taken to assure current and future lots of marketed product meet compendial and NDA requirements"...