Warning Letter — PolleyMed, LLC
The FDA issued a Warning Letter to PolleyMed, LLC on May 14, 2026, following an evaluation by the Center for Drug Evaluation and Research (CDER).
PolleyMed, LLC and personnel responsible for drug manufacturing, labeling, and regulatory compliance within the organization.
The issuance of a Warning Letter by CDER indicates significant regulatory non-compliance, typically involving the marketing of unapproved new drugs or violations of Current Good Manufacturing Practice (CGMP). This suggests potential gaps in the firm's quality management system or regulatory filing strategy, which may lead to administrative or judicial action if not remediated.
Regulatory and Quality teams should conduct an immediate audit of product listings and marketing claims to ensure lack of unapproved drug status. Organizations should verify that all products marketed as drugs have obtained necessary FDA approvals or fall within established monographs.
FDA Warning Letter issued to: PolleyMed, LLC. 05/14/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/polleymed-llc-726018-05142026
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