Warning Letter — Tides Medical LLC
The FDA Center for Biologics Evaluation and Research (CBER) issued a warning letter to Tides Medical LLC following an inspection of their operations.
This affects Tides Medical LLC, as well as regulatory and quality personnel involved in the manufacturing and distribution of biological products and HCT/Ps.
A warning letter from CBER typically indicates significant deviations from Current Good Tissue Practice (CGTP) or Current Good Manufacturing Practice (CGMP) requirements. For manufacturers in the biologics space, this suggests potential risks to product safety, purity, or potency, and may lead to escalated enforcement if remediation is not prioritized. The source does not specify the exact violations, but the involvement of CBER implies the products in question are regulated as biologics or HCT/Ps.
Regulatory and QA departments should review current HCT/P processing procedures to ensure strict alignment with CBER standards and confirm all biological products are distributed under appropriate regulatory pathways. Internal audits should verify that product claims do not exceed the scope of the current registration or licensure.
FDA Warning Letter issued to: Tides Medical LLC. 10/06/2026 — Center for Biologics Evaluation and Research (CBER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tides-medical-llc-727246-10062026
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