85%Confidence
0Views
FDASource
2026-04-05Date
Summary
Further CGMP deviations for Acme United's bulk antiseptic towelettes confirm systemic manufacturing quality problems across their product portfolio. This pattern suggests deep-rooted compliance issues that may require significant remediation efforts and could affect their ability to serve institutional customers.
Actionable: Initiate supplier quality audits for all Acme United products and develop contingency sourcing plans for critical medical supplies.
AI Confidence: 85%
Data Points
firmACME UNITED CORPORATION
classificationClass II
statusOngoing
distributionNationwide within the United States
productFirst Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Ma
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