FDA 483 - Willow Birch Pharma, Inc. - May 03, 2024
Discuss this record with AI
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.
Willow Birch Pharma, Inc. in Taylor, MS, an API repackager/relabeler, was cited for a significant lack of control over computer systems and related records during an FDA inspection. The firm failed to implement appropriate access controls and audit trails for electronic software used to generate labels and for word documents used to create certificates of analysis for repackaged active pharmaceutical ingredients. This indicates a serious deficiency in data integrity and record management practices.
ID · 738a0558-21ee-4b12-ae88-67aec0d79fd6