FDA EIR - Aliri USA Inc. - February 20, 2013

An FDA abbreviated drug contract laboratory inspection was conducted at Pyxant Labs, Inc. in Colorado Springs, CO, from February 19-20, 2013. The inspection, performed under CPGM 7356.002H, confirmed the firm no longer performs finished drug product testing. While no FDA-483 observations were issued, a significant discussion item was raised regarding the firm's practice of not completing method validation prior to analyzing patient samples in more than one instance. Pyxant Labs agreed to immediately rectify this objectionable condition.

Previous inspections revealed several issues. A 2009 inspection noted deficiencies including a quality control unit failing to investigate out-of-specification data, improper chromatographic peak integration, unvalidated spreadsheet calculations with unprotected formulas, lack of written procedures for "Data Not Used" forms, and rodent droppings with inadequate pest control. An earlier 2007 inspection also cited SOP deviations for analytical runs and missing reasons for repeat analyses in final reports. The current inspection focused on quality and laboratory systems for their ongoing bioanalytical support for regulatory studies, which establishes FDA jurisdiction.