90%Confidence
1Views
FDASource
2026-03-26Date
Summary
Acme United's repeated CGMP deviations across multiple antiseptic towelette products suggest systemic quality management failures that could damage brand reputation across their private label customers. The pattern indicates potential widespread manufacturing issues that may trigger broader regulatory action.
Actionable: Evaluate exposure to Acme United manufactured products and consider diversifying suppliers for antiseptic products.
AI Confidence: 90%
Data Points
firmACME UNITED CORPORATION
classificationClass II
statusOngoing
distributionNationwide within the United States
productMed Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT
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