Aliri USA Inc. – FDA EIR, Aug 30, 2013

An FDA inspection of Pyxant Labs, Inc., a bioequivalence analytical laboratory in Colorado Springs, CO, was conducted from August 26-30, 2013. This comprehensive pre-approval data validation inspection adhered to CDER ANDA and GLP Compliance guidelines, specifically under Compliance Program 7348.001 for In Vivo Bioequivalence.

The inspection identified significant issues, resulting in a three-item FDA-483. Key violations included the failure to control carryover and contamination in assays, leading to analyte detection above quantification limits and quality control failures in multiple analytical runs. The firm also failed to evaluate potential interference between different drugs during quantification in human plasma. Additionally, Pyxant Labs, Inc. did not control the matrix effect in numerous mass spectrometry runs, causing significant variability in the internal standard signal.

Maurice A. Gaubatz, the company's President and CEO, acknowledged these deviations and committed to providing a written response within 15 business days. FDA sanctions were discussed with management at the inspection's conclusion, requiring the laboratory to address the identified deficiencies to meet regulatory standards for bioanalytical studies.