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FDA Warns Luminex for Validations, Process Changes

July 22, 2020

Luminex began using heater fixtures produced by a new component manufacturer in 2019, but implemented the change without an approved validation plan, according to a June 26 warning letter from the FDA.

The firm manufactures microsphere-based and PCR-based multiplexing systems for in vitro diagnostic use. During a Feb. 10-14 inspection of the firm’s Austin, Texas, facility, the FDA found that the firm failed to validate a manufacturing change for its calibration heater test fixtures to verify the Verigene SP Class II device for clinical multiplex test systems.

The agency received responses dated March 9, April 10, May 8 and June 9, but the responses were deemed inadequate because they didn’t address process changes between the two heating fixtures, and there was no statistical rationale for why a minimum number of tests were conducted.

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