FDA WARNING_LETTER - Pure Indulgence Aesthetics - December 12, 2025

Pure Indulgence Aesthetics, a medical spa in Southlake, Texas, received an FDA warning letter following inspections on December 2, 3, and 12, 2025. The agency identified significant violations of the Drug Supply Chain Security Act (DSCSA), a regulatory framework established to protect patients from counterfeit, stolen, or contaminated medications. The primary violation involved the sourcing of botulinum neurotoxin products, such as Botox. Investigators discovered a substantial discrepancy between the amount of authentic Botox purchased from authorized distributors and the much larger quantity documented in patient treatment records. This indicates the facility likely obtained prescription drugs from unauthorized trading partners. Furthermore, the FDA found unlabeled vials containing botulinum neurotoxin in the facility"s waste, which lacked the required product identifiers necessary for tracking and safety verification. These findings are critical because botulinum toxin carries a "black box warning" for potentially life-threatening side effects, and improper sourcing compromises the ability to perform safety recalls. The FDA deemed the company"s initial response to these findings inadequate as it lacked documentation for new safety protocols or a clear explanation for the supply discrepancies. Pure Indulgence Aesthetics is required to submit a written response within 15 working days detailing the corrective steps taken and providing evidence of new policies to ensure future compliance. Failure to address these concerns may result in legal actions, including product seizures or injunctions.