FDA 483 - Pure Indulgence Aesthetics - December 02, 2025

During an inspection conducted from December 2 to December 12, 2025, Pure Indulgence Aesthetics, a dispenser of prescription drugs in Southlake, Texas, received an FDA Form 483 highlighting significant observations regarding drug supply chain integrity. The primary issues identified relate to non-compliance with the Drug Supply Chain Security Act (DSCSA), specifically under FD&C Act Sections 582(d)(3) and 582(d)(2).

Inspectors observed that the firm failed to conduct business exclusively with authorized trading partners. Patient treatment records indicated a substantially higher volume of Botox (onabotulinumtoxinA) administered than could be supported by documented purchases from AbbVie, the sole legitimate U.S. supplier. This discrepancy strongly suggests the firm obtained product from unauthorized sources.

Furthermore, Pure Indulgence Aesthetics failed to engage in transactions involving only products with a valid product identifier. An unlabeled vial containing botulinum neurotoxin type A, which did not resemble legitimate Botox vials, was found lacking proper labeling and a product identifier. Pure Indulgence Aesthetics is required to address these deficiencies to ensure full compliance with federal regulations governing the secure and legitimate supply chain of prescription drugs by providing a detailed response outlining corrective actions.