FDA 483 - Sachem Europe BV - February 06, 2020

Sachem Europe BV, an API Intermediate Manufacturer in Zaltbommel, Gelderland, Netherlands, was inspected by the FDA from February 3-6, 2020. The inspection resulted in one observation concerning the firm's failure to fully follow written laboratory control procedures. Specifically, deviations were noted in HPLC analysis run times without proper documentation.