Warning Letter — DesBio/Deseret Biologicals, Inc.
The FDA issued a Warning Letter to DesBio/Deseret Biologicals, Inc. on October 1, 2026, following an evaluation by the Center for Drug Evaluation and Research (CDER).
DesBio/Deseret Biologicals, Inc. and personnel responsible for drug labeling, marketing, and regulatory submissions within the organization.
A Warning Letter from CDER typically indicates significant violations of the Federal Food, Drug, and Cosmetic Act, often related to the marketing of unapproved new drugs or misbranding. This action suggests that the firm's current manufacturing or labeling practices may not meet federal standards, potentially leading to further enforcement actions if not remediated.
Conduct a comprehensive review of all product labeling and marketing materials to ensure no unauthorized therapeutic claims are present. Regulatory teams should verify that all products marketed as drugs have the necessary FDA approvals or meet monograph requirements.
FDA Warning Letter issued to: DesBio/Deseret Biologicals, Inc.. 10/01/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/desbiodeseret-biologicals-inc-735464-10012026
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