82%Confidence
0Views
FDASource
2026-04-05Date
Summary
Additional CGMP deviations for Dynarex-branded towelettes manufactured by Acme United indicate widespread quality control problems that may extend across their entire manufacturing network. This could trigger broader regulatory action and impact multiple distribution partnerships in the medical supplies industry.
Actionable: Assess the risk exposure across all Acme United manufactured products and implement enhanced incoming quality checks.
AI Confidence: 82%
Data Points
firmACME UNITED CORPORATION
classificationClass II
statusOngoing
distributionNationwide within the United States
productDynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Or
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