FDA 483 - Sonneborn, LLC - August 20, 2025

An FDA Form 483 was issued to Chad Bell, Director of Operations, for an unnamed firm following an inspection conducted from August 18-20, 2025, in Philadelphia, PA. The inspection revealed significant concerns regarding data integrity and computer system controls. The primary observation noted a lack of appropriate controls to ensure that changes to master production and control records, as well as other critical data, are made only by authorized personnel. Specifically, the firm's chemistry laboratory lacked unique user IDs and passwords for analysts using analytical instruments like GC/HPLC. This deficiency allowed for a general administrative login, enabling any user to create, modify, or delete methods and records without proper accountability. Furthermore, the firm was not conducting reviews of audit trails to verify data accuracy. Additionally, a key computer software system, used for managing production records, inventory, planning, and scheduling, had not been validated. This absence of validation means there is no assurance that information within the system cannot be improperly deleted or altered, posing a substantial risk to data reliability. These observations indicate a failure to maintain adequate control over electronic data and systems, which is foundational to regulatory compliance. The firm is required to implement comprehensive corrective actions to address these critical deficiencies, ensuring data integrity, system security, and appropriate user access controls.