483
Silgan Unicep Packaging LLCSilgan Unicep Packaging LLC – FDA 483, Feb 28, 2014
Record Details
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.
View Company Profile
ID · a77638b4-f9b7-43f4-96bb-da63cc24ff19
Other documents for Silgan Unicep Packaging LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.