FDA: Meeting, Audit Needed After Inspection of Dx Maker

The FDA has requested a meeting with Express Diagnostics International, as well as an independent audit of the company’s manufacturing practices, following an inspection that uncovered problems with testing and labeling of the company’s products.

Officials from the Blue Earth, Minn., company, which makes drug abuse test kits, were asked to visit the FDA’s Minneapolis office to discuss the inspection, corrective and preventive actions related to a complaint of false positive results and practices regarding “forensic use only” labeling. “In particular, we are concerned about whether your products have the required premarket clearances for the manner in which they are being promoted and distributed,” the agency said in a Sept. 17 warning letter, recently released.

The FDA also has requested an audit and certification by an outside consultant by Dec. 12, with subsequent certifications of updated audits and corrections over the next two years. The agency will conduct a follow-up inspection to verify that Express Diagnostics has followed through on corrective actions.

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