FDA 483 - Willow Birch Pharma, Inc.

During an FDA inspection conducted from April 30 to May 3, 2024, Willow Birch Pharma, Inc., an API Repackager/Relabeler, received a Form FDA 483. The primary observation highlighted a critical lack of appropriate controls over computer and related systems, impacting data integrity and regulatory compliance. Specifically, the firm's electronic software for generating labels for repackaged Active Pharmaceutical Ingredients (APIs) did not require unique username/password combinations for access or activities. This absence of control meant no data capture for user-generated or deleted information within the software. Additionally, the company produced Certificates of Analysis (COAs) using an uncontrolled word document, similarly lacking unique user authentication and monitoring capabilities for creation, deletion, or distribution of these vital documents. Both the labeling software and the COA generation process critically lacked audit trail functionality, which is essential for maintaining a secure and traceable record of changes. These observations indicate non-compliance with regulatory expectations for data integrity and system security under the Federal Food, Drug, and Cosmetic Act. Willow Birch Pharma, Inc. is required to implement robust corrective actions to establish secure access, user authentication, and comprehensive audit trails for all relevant electronic systems to ensure the reliability and trustworthiness of its production and control records.