Tailstorm Health Inc. dba Medivant Health
FDA issued a warning letter to Tailstorm Health Inc. dba Medivant Health (Phoenix, AZ), an outsourcing facility registered under section 503B, following a September–October 2024 inspection that found serious sterility and CGMP deficiencies. The facility's compounded drug products — including Semaglutide Injection, Tirzepatide Injection, and Bevacizumab — were found adulterated due to insanitary conditions, inadequate microbial contamination response, and deficient smoke studies, and were also deemed unapproved new drugs and misbranded. FDA demanded a written corrective action response within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (3)
Your facility's drug products, such as Semaglutide Injection 1mg/0.2ml and Tirzepatide Injection 2.5mg/0.5ml, did not include the following on the label: "Office Use Only."
their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA
You do not have any FDA-approved applications on file for drug products that you compound.
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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