BotableBook a call
FDA Warning Letter Explorer
FDA warning letter · Drugs

Tailstorm Health Inc. dba Medivant Health

Issued · Posted by FDA

FDA published a close-out letter on Apr 14, 2026. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.

Passage 2

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 3

Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 200.10(b)
  • 21 CFR 201.115
  • 21 CFR 210
  • 21 CFR 210.1(b)
  • 21 CFR 211.192
  • 21 CFR 211.42(c)(10)(iv)
  • 21 CFR 310.305(b)
  • 21 CFR 310.305(e)