Warning Letters → CMS-684109
Warning Letter CMS-684109 · Issued 2025-12-10
Open — Awaiting Verified Remediation Closeout
Carolina Infusion LLC — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.165(a), 21 CFR 211.110(a))
Issuing FDA Office: FDA Center for Drug Evaluation and Research (CDER) · Facility FEI: 3015826782
Cited Federal Regulations (Click to Open 21 CFR Clause Encyclopedia):
What FDA Demanded Within 15 Working Days:
Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
GMPGraph Forensic Autopsy · Form 483 → Warning Letter Escalation
How This Inspection Escalated Into Formal Enforcement
Est. Remediation & Consultant Cost
$185,000 – $640,000 (Consultant overhaul + retrospective lot testing + delayed SKU launches)
How AI Mock Inspection Prevents This Escalation ($149 vs. $250K+):
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