90%Confidence
0Views
FDASource
2026-03-23Date
Summary
Acme United's repeated CGMP deviations across multiple antiseptic towelette products suggest systemic manufacturing quality issues, potentially affecting multiple brands and retail partners. This could lead to supply chain disruptions and increased regulatory oversight for over-the-counter medical products.
Actionable: Evaluate supply chain dependencies on Acme United for antiseptic products and consider alternative suppliers for risk mitigation.
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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