FDA Resumes Domestic Surveillance Inspections but Faces Huge Backlogs
They’re baaaack! FDA surveillance inspectors returned to the beat on Monday, at least for domestic operations. On Dec. 31, the agency announced a temporary freeze on all but “mission-critical” inspections to protect inspectors from Omicron. The freeze, the second...
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Agency Continues Crack Down on Unauthorized COVID-19 Tests
On Jan. 11, the FDA warned consumers not to use COVID-19 tests from LuSys Laboratories, as they have not been approved for use in the US.
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Federal Enforcers Crack Down on Fraudulent Billing of Genetic Tests
Labs that bill federal health care programs for these tests need to pay especially close attention to ensure compliance.
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