90%Confidence
0Views
FDASource
2026-03-18Date
Summary
Acme United's CGMP deviations across multiple antiseptic towelette products suggest systemic quality control issues that could lead to lost contracts and regulatory penalties. The repeated violations across different product lines and customers indicate deeper operational problems that may require significant remediation investment.
Actionable: Evaluate exposure to Acme United as a supplier and assess alternative antiseptic wipe manufacturers for business continuity.
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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