FDA 483 - PathoQuest, Inc. - October 31, 2025

During an inspection conducted from October 28 to October 31, 2025, the FDA issued a Form 483 to PathoQuest, Inc., a control laboratory located in Wayne, PA. The inspection revealed significant concerns regarding the firm's control over computer systems and related electronic data, indicating a failure to assure data integrity and system security. The primary observation noted that appropriate controls were not exercised over computer systems to ensure that changes to records were instituted only by authorized personnel. Specifically, several critical issues were identified: 1. On the Qubit Flex instrument, users had the ability to change dates, times, and delete data. Electronic data records were not reviewed, with audit trail review limited solely to paper printouts. 2. Similarly, on the Bioanalyzer 2100 Laptop, users could alter date and time settings. Electronic data generated was not reviewed by Quality Assurance, and audit trail review was confined to paper printouts. 3. The MiSeq instrument, while equipped with audit trail functionality, had not configured these trails to record system activities. Furthermore, no personnel were assigned to review audit trail data, and both Quality Control and Quality Assurance staff lacked the necessary user access privileges to review audit trails. These observations highlight a critical deficiency in meeting regulatory expectations for data integrity and system control in a laboratory environment. PathoQuest, Inc. is required to implement comprehensive corrective actions to address these issues, ensuring proper user access controls, complete audit trail functionality, and effective review processes for all electronic data records.