FDA 483 - Willow Birch Pharma, Inc. - May 03, 2024

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.