Aliri USA Inc. – FDA EIR, Sep 21, 2018

An FDA inspection of Pyxant Labs, Inc. was conducted from September 17-21, 2018, focusing on Good Laboratory Practice (GLP) activities under Compliance Program 7348.808. The inspection concluded without issuing an FDA 483, indicating no objectionable conditions warranting formal observations were found. However, a detailed discussion with management at the closeout meeting identified several areas for procedural improvement.

Key recommendations included ensuring chemists' qualifications are fully reviewed and approved before commencing sample analysis, and implementing robust documentation for temperature excursions and non-conformances, especially after issues with an employee's late entries and self-review. The firm was also advised to thoroughly manage obsolete Standard Operating Procedures (SOPs) by removing them from circulation and ensuring proper archiving. Further recommendations addressed access controls for electronic archives, requiring proper designation for IT personnel with full access. Management was advised to update the server room SOP to include optimal operating temperatures and corrective action protocols for excursions. Other critical points included controlling equipment use logs with paginated documents, providing explanations for late entries, and implementing a formal change control log. The inspection also noted inconsistencies between analysis worksheets and the bioanalytical method, and a lack of clear identification for repeated steps on worksheets, both of which the firm confirmed were already corrected for new studies. Pyxant Labs committed to addressing all identified areas, with various timelines for implementation.