NEW YORK ─ Luminex said on Monday that it has received a warning letter from the US Food and Drug Administration related to operations in its Austin, Texas, and Northbrook, Illinois, facilities and its Verigene Processor SP System.
In a document filed with the US Securities and Exchange Commission, the firm said that the warning letter results from inspections held at the facilities from Feb. 10, 2020 to Feb. 14, 2020, and that it pertains to FDA requirements for the Verigene SP instrument and its hybridization heater.
According to the Luminex website, the Verigene Processor SP is a modular, easy-to-use benchtop analyzer that combines automated nucleic-acid extraction, purification, amplification, and hybridization in each module, allowing users to run tests on-demand without the need for batch processing, specially trained personnel, or specialized facilities.
Luminex said in the SEC document that it takes "matters identified in the warning letter very seriously and intends to submit a response to FDA regarding the issues raised" within 15 business days.
In its warning letter to Luminex dated June 26 and posted to the agency's website on July 7, the FDA said that the firm "has not adequately validated, reviewed, or approved [a] manufacturer change for the calibration heater test fixtures." Additionally, the agency said, Luminex's personnel has "not adequately followed the corrective and preventive action standard operating procedure … that requires immediate containment of the affected product or process without undue delay."
Among the list of violations at the Luminex facility, the FDA also said that the company has not kept calibration records and verification results on device servicing since 2016, and it did not establish and maintain quality requirements that must be met by its suppliers.