Pure Indulgence Aesthetics
FDA issued a warning letter to Pure Indulgence Aesthetics, a medical spa in Southlake, TX, following a December 2025 inspection that revealed the facility dispensed significantly more Botox units to patients than it had purchased from the authorized manufacturer (AbbVie), indicating procurement from unauthorized trading partners in violation of the Drug Supply Chain Security Act (DSCSA). Investigators also found an unlabeled vial containing botulinum neurotoxin type A in the facility's trash that lacked required product identifiers and did not match authentic AbbVie Botox packaging. The facility's December 2025 response to the FDA 483 was deemed inadequate for failing to address the purchase-dispensing discrepancy, provide supporting documentation, or establish forward-looking compliance procedures. FDA warned that failure to correct violations may result in seizure and injunction.
Flagged claims (3)
your firm dispensed significantly more Botox units than documented purchases from AbbVie (the manufacturer of Botox), thereby indicating a major discrepancy
your firm obtained product from unauthorized sources (i.e., entities that are not authorized trading partners) and then claimed such product was authentic AbbVie Botox
the Facility prohibits storage or use of prescription drug products outside original manufacturer packaging
Required actions (3)
Within fifteen (15) working days of your receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations identified in this warning letter.
Correct any violations promptly. Failure to promptly and adequately address the violations described herein may result in regulatory or legal action without further notice, including seizure and injunction.
Failure to promptly and adequately address the violations described herein may result in regulatory or legal action without further notice, including seizure and injunction.
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