85%Confidence
0Views
FDASource
2026-03-21Date
Summary
Additional Acme United CGMP deviations for bulk antiseptic towelettes confirm widespread quality system deficiencies across multiple manufacturing locations. This pattern suggests the company may face significant remediation costs and potential production halts until compliance is restored.
Actionable: Diversify antiseptic product sourcing immediately and monitor FDA enforcement actions against Acme United.
AI Confidence: 85%
Data Points
firmACME UNITED CORPORATION
classificationClass II
statusOngoing
distributionNationwide within the United States
productFirst Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Ma
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