FDA WARNING_LETTER - Tailstorm Health Inc. dba Medivant Health - October 10, 2024

On April 8, 2025, the FDA issued a Warning Letter to Tailstorm Health Inc. dba Medivant Health, an outsourcing facility registered under section 503B of the FDCA. An inspection from September 24 to October 10, 2024, revealed serious deficiencies in producing sterile drug products, risking patient safety.

Violations included failure to meet 503B conditions, such as missing "Office Use Only" labels on products like Semaglutide and Tirzepatide Injections, and inadequate adverse event reporting procedures (e.g., not defining "unexpected" events or specifying FDA's Safety Reporting Portal for submissions). These failures render their compounded drugs ineligible for 503B exemptions from FDA approval, adequate directions for use, and Drug Supply Chain Security Act requirements.

The facility's drug products were deemed adulterated under FDCA sections 501(a)(2)(A) and 501(a)(2)(B) due to insanitary conditions and CGMP violations. Specific issues included inadequate product evaluation after microbial contamination in the ISO 5 area, insufficient dynamic smoke studies, failure to investigate discrepancies, and inadequate environmental monitoring.

Consequently, the firm's unapproved new drug products and misbranded drug products (lacking adequate directions for use for non-self-diagnosable conditions) violate FDCA sections 505(a), 3