A Regulatory Letter (RL) is formal correspondence issued by a regulator or oversight body to communicate inspection outcomes, findings, requests, or required actions.
In FDA-regulated environments, regulatory letters may follow inspections and can request documentation, outline concerns, or require corrective actions within specific timelines. RLs are high-value compliance records because they document the regulatorís expectations and the organizationís response obligations. Effective RL management includes triage, assignment of owners, documented response plans, and tracking of CAPA to closure. Strong regulatory correspondence handling supports inspection readiness and demonstrates accountable governance.