FDA EIR - UFAG Laboratorien AG - October 09, 2006

An FDA pre-approval and Good Manufacturing Practice (GMP) inspection was conducted at UFAG Laboratorien AG in Sursee, Switzerland, from October 6-9, 2006. This initial inspection focused on the contract testing laboratory's compliance with regulatory standards for drug product analysis, particularly for two investigational products: (b) (4) % (a medicated article) and (b) (4) mg capsules. The inspection was carried out under FDA Compliance Policy Guides for pre-approval and drug manufacturing inspections.

Several significant deficiencies were identified and cited in an FDA-483. For the (b) (4) % product, issues included a lack of specific instructions for forced degradation studies, no evaluation of the active ingredient's degradation percentage, and omitted peak purity evaluations. Furthermore, the impurities method failed to assess resolution between critical peaks. For the (b) (4) capsules, the inspection found no written protocols with predefined acceptance criteria for method validation prior to execution, an insufficient discussion of forced degradation adequacy in the validation report, and the absence of peak purity evaluations. Additionally, accuracy results for impurity concentrations were averaged rather than evaluated individually.

Dr. Thomas Bischofberger, Managing Director, received the FDA-483. Management acknowledged the observations and committed to submitting a written response to the FDA within 10-15 days, outlining their corrective actions.