Pure Indulgence Aesthetics - DSCSA Trading Partner and Product Tracing Violations

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Bridget M. Goddard Recipient Title Manager Pure Indulgence Aesthetics 1695 East Southlake Boulevard Suite 150
Southlake, TX 76092
United States

info@pureindulgenceaesthetics.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States

Warning Letter 723267

April 1, 2026

FEI: 3041017461

Ms. Goddard:

The U.S. Food and Drug Administration (FDA) inspected your facility, Pure Indulgence Aesthetics (Pure Indulgence), FEI 3041017461, 1695 East Southlake Boulevard Southlake, TX 76092, on December 2nd, 3rd, and 12th, 2025. You identified yourself as the manager and the most responsible person at the facility.

The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54), enacted by Congress on November 27, 2013, added section 582 to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 582 of the FD&C Act (21 U.S.C. 360eee-1) specifies the requirements that certain entities in the pharmaceutical distribution supply chain (including dispensers, as defined by the DSCSA) must follow related to product tracing, product identification, verification, and authorized trading partners.

Pure Indulgence operates as a medical spa under the supervision of a medical doctor. Certain employees working at Pure Indulgence are authorized to dispense and administer human prescription drugs under this medical doctor’s direction and supervision. The DSCSA includes in its definition of a dispenser any “person authorized to dispense or administer human prescription drugs.” Pure Indulgence therefore operates as a “dispenser” under section 581(3) of the DSCSA, and your firm is subject to certain provisions of section 582(d) of the FD&C Act.

This warning letter summarizes significant violations by your firm of requirements in section 582(d) of the FD&C Act. These requirements are intended to help preserve the security of the supply chain for certain prescription drug products, thereby protecting patients from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

FDA issued a Form FDA 483 to Pure Indulgence at its Southlake, Texas facility on December 12, 2025. Observations highlighted FDA’s concerns about Pure Indulgence’s sourcing of botulinum neurotoxin type A products. FDA reviewed Pure Indulgence’s response submitted on December 17, 2025.

Furthermore, FDA-approved botulinum toxin products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning indicates the product may cause symptoms of botulism, which attacks the body’s nerves and causes muscle weakness that can lead to difficulty breathing and even death.

DSCSA Violations

During FDA’s inspection, our investigators observed that your firm failed to comply with various requirements of the DSCSA. Specific violations include, but may not be limited to, the following:

1. Your firm was unable to demonstrate compliance with the requirement to conduct transactions with only authorized trading partners (FD&C Act Section 582(d)(3)).

Under section 582(d)(3) of the FD&C Act, trading partners of a dispenser must be authorized trading partners. A trading partner is considered authorized if it meets the definitions established in section 581(2) of the FD&C Act.

During the inspection, FDA conducted a thorough analysis of your firm’s purchase records and patient dispensing records with respect to Botox® (onabotulinumtoxinA), a botulinum neurotoxin type A product. It was determined that your firm dispensed significantly more Botox units than documented purchases from AbbVie (the manufacturer of Botox), thereby indicating a major discrepancy.

Purchase records provided by both your firm and AbbVie (an authorized trading partner in accordance with section 581(2)(A) show your firm received (b)(4) vials ((b)(4) units) from AbbVie between December 18, 2024, and December 01, 2025. Patient treatment records, however, indicate that your firm administered product identified as “Botox” to (b)(4) patients between January 1, 2025, and December 1, 2025, with an estimated (b)(4) units dispensed. This represents a discrepancy of (b)(4) units (approximately (b)(4) vials) between the amount of Botox indicated in your purchase records and the amount of product administered to patients. During the inspection, you indicated that you would expect to dispense approximately (b)(4) vials of Botox, or (b)(4) units (b)(4). When asked by FDA how much Botox is typically ordered, you noted that you place about (b)(4). These descriptions of purchasing and dispensing align with what is indicated in the patient treatment records, but not with the records provided to FDA by both your firm and AbbVie documenting actual purchasing of Botox. 1 During the inspection, you did not provide any explanation or justification for the discrepancy between the purchase records and treatment records.

FDA also notes that the (b)(4) purchase orders you made for Botox from AbbVie dating back to December 2024 were all for (b)(4) vials. The only purchase record you were able to provide demonstrating a purchase of (b)(4) vials was for an order placed on December 2, 2025, after FDA investigators arrived and were actively conducting the inspection.

Based on records summarized above and reviewed by FDA, your firm did not purchase enough Botox from AbbVie to supply patients with the quantity of authentic Botox indicated in patient records. This discrepancy shows that 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. Based on the thorough review of your purchasing records and patient treatment records, you have been unable to demonstrate compliance with the requirement under section 582(d)(3) to conduct transactions only with authorized trading partners.

2. Your firm failed to engage in transactions involving only product with a product identifier (FD&C Act Section 582(d)(2))

Under section 582(d)(2) of the FD&C Act, a dispenser may only engage in transactions 2 involving a product 3 if that product is encoded with a product identifier. A product identifier, as defined in section 581(14) of the FD&C Act, is a standardized graphic that includes, in both human and machine-readable format, the product’s standardized numerical identifier, 4 the lot number, and the expiration date of the product. Under section 582(b)(2) and (e)(2) of the FD&C Act, manufacturers and repackagers are required to affix or imprint product identifiers to packages and homogenous cases of product. 5

During the inspection, FDA identified an unlabeled, clear vial containing a ring of white powder disposed of in your facility's trash. While you denied any knowledge or recognition of this product, you identified yourself as the most responsible person during the inspection. FDA later confirmed by laboratory analysis that this vial contained botulinum neurotoxin type A, the same active ingredient as Botox. The shape of the unlabeled vial found at your facility was not the same as an authentic vial of Botox manufactured by AbbVie. 6

FDA investigators asked if you were able to provide a label or packaging for this product with required information, including a product identifier. In response, you denied any knowledge of the product and claimed not to recognize it. Therefore, you provided no evidence that the unlabeled, clear vial had been in a package or homogenous case that properly contained a required product identifier.

An onabotulinumtoxinA product, such as Botox, is a prescription drug and is a “product” as defined by 581(13) of the FD&C Act. The product found at your facility lacked proper labeling and you were unable to provide a label or packaging that contained a product identifier, as required under section 582(d)(2).

Your Response to the FDA Form 483

FDA has reviewed your December 17, 2025, response to our Form FDA 483 in detail. FDA acknowledges the corrective actions Pure Indulgence describes in its response, but FDA finds Pure Indulgence’s response to be inadequate. Pure Indulgence’s response does not provide information about how you will ensure compliance with the DSCSA requirements in the FD&C Act moving forward, and your response lacks any supporting documentation such as new policies and procedures to ensure compliance or a description of how trading partner status will be verified. In addition, Pure Indulgence’s response does not address the large discrepancy between the amount of Botox purchased from AbbVie and the amount of product administered to patients.

Other reasons Pure Indulgence’s response is insufficient include, but are not limited to, the following:

• Your response notes that you performed a retrospective review of purchasing records, administration documentation, and patient charts related to botulinum toxin administration and determined that no adverse events were identified. It is impossible for FDA to verify this statement since you did not provide any documentation or identify the products you dispensed and administered to patients at your facility, making a true evaluation of adverse events or potentially applicable recalls impossible. In addition, FDA cannot evaluate your review because you have not provided any documentation or explanation about how you conducted your adverse event evaluation. This is particularly concerning from a public health perspective given that FDA-approved botulinum neurotoxin type A products contain a boxed warning. The ability to conduct a speedy and effective recall of drug products when necessary is critical to public health. When a facility obtains drug products from unauthorized sources and does not have safeguards in place to identify adverse events, effective recalls are not possible.
• Your response notes that you have appointed a designated “drug custodian” with sole responsibility and authority for ordering and receiving prescription drugs; however, you provide no documentation demonstrating who that individual is or providing their qualifications. Based on the response, there is no reason to believe that you, Bridget Goddard, are not the drug custodian. This is especially concerning given the observations in the warning letter. Further we note that you have a history of obtaining unapproved products from foreign, unverified sources. 7
• At the inspection, FDA investigators were told of your firm’s practice of drawing product identified as Botox into 10-unit syringes and holding a supply of pre-filled syringes at the facility to be administered to patients. Your response states that “the Facility prohibits storage or use of prescription drug products outside original manufacturer packaging.” However, without further detailed protocols in place, we are concerned that you will continue to remove the product from manufacturer vials prior to administration to patients. Conclusion

Pure Indulgence’s response to FDA Form 483 does not indicate that sufficient remediation efforts have been taken. FDA is sending this advisory letter to Pure Indulgence because of the inherent risk to patients introduced through your firm’s aforementioned actions.

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

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.

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. Please include an explanation of each step being taken to prevent the recurrence of violations and include copies of related documentation. If you disagree with the characterization of the violations of the FD&C Act in this warning letter, include your reasoning and any supporting information for our consideration. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the corrections.

Please send your electronic reply, or any questions regarding the contents of this letter, to: DSCSAInspections@fda.hhs.gov.

Please identify your responses with the unique identifier: CMS 723267.

Sincerely,
/S/

Sangeeta Vaswani Chatterjee, Pharm.D.
Director
Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research

1 There was no discrepancy between the purchase records provided by both Pure Indulgence and AbbVie to FDA.

2 As defined in section 581(24) of the FD&C Act.

3 As defined in section 581(13) of the FD&C Act.

4 As defined in section 581(20) of the FD&C Act.

5 “Package” and “homogenous case” as defined in sections 581(11) and 581(7), respectively, of the FD&C Act. As specified in section 581(11), “package” means the smallest individual saleable unit of product for distribution by a manufacturer or repackager that is intended by the manufacturer for ultimate sale to the dispenser, and “individual saleable unit” means the smallest container of product introduced into commerce by the manufacturer or repackager that is intended by the manufacturer or repackager for individual sale to a dispenser.

6 This product is not a compounded drug, which is not a “product” for purposes of the DSCSA per section 581(13), because it does not meet relevant requirements for drug compounding under sections 503A and 503B of the FD&C Act.

7 https://www.justice.gov/usao-cdca/pr/nurse-who-operated-spa-laguna-niguel-agrees-plead-guilty-illegally-dispensing-botox-not

• ## Content current as of:

04/09/2026

• Regulated Product(s)

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