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🏥 FDA: ACME UNITED CORPORATION — Class II

healthcarebearishSource: FDA
80%Confidence
0Views
FDASource
2026-03-29Date

Summary

Acme United's CGMP deviations for antiseptic towelettes suggest systemic quality control problems across multiple product lines, potentially affecting brand reputation and regulatory standing. The repeated violations indicate inadequate corrective actions and may lead to more severe regulatory actions.

Actionable: Review all Acme United antiseptic products in inventory and consider diversifying suppliers for infection control products.

AI Confidence: 80%

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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