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March 20, 2026
20
Mar

WARNING LETTER: QMS Inadequacies

March 20, 2026
WARNING LETTER Exactech, Inc. dba Advita Ortho was issued a warning letter from the FDA. Excerpts from a warning letter of interest to SoftwareCPR® clients. CMS # 720250 2320 Nw 66th Ct Gainesville, FL 32653-1630 Date of inspection July 15-25, 2025 Inspection Issues: Quality System Regulation Violations This inspection revealed that these devices are adulterated...
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