SYNTEX CLEANING VALIDATION PROCEDURES DRAW WARNING LETTER

Executive Summary

SYNTEX CLEANING VALIDATION PROCEDURES DRAW WARNING LETTER from FDA May 6. An inspection of Syntex' Palo Alto, Calif. manufacturing facility in February and March "revealed serious deficiencies in the cleaning validation procedures for the solids, liquids, creams and ointments manufactured at the facility," FDA's San Francisco District Office told Syntex. "The inspection showed that both the cleaning validation studies completed in 1988 and the ongoing verification program are seriously flawed," the letter states.