FDA 483 - Silgan Unicep Packaging LLC - February 28, 2014

An FDA inspection of Unicep compounding, filling & packaging in Sandpoint, ID, revealed two significant quality system deficiencies. The firm failed to adequately establish procedures for corrective and preventive actions, as evidenced by an unresolved issue with leaking pipettes. Additionally, procedures for routine equipment calibration were found to be inadequate, with a balance operating outside its acceptable tolerance range without proper action.