FDA 483 - UFAG Laboratorien AG - October 06, 2006

UFAG Laboratorien AG, a contract test laboratory in Sursee, Switzerland, was cited for deficiencies in its stability program and analytical method validation for drug products. Observations included a lack of reliable, meaningful, and specific test methods, inadequate forced degradation studies, and insufficient evaluation of peak purity and accuracy results. The findings indicate issues with the firm's quality control and analytical testing procedures.