Philadelphia 7, Inc d/b/a Passional Boutique

For example, our review of your firm’s website revealed that you are distributing the UNTAG line of binders, which its manufacturer, Trans-Missie B.V., claims are intended for “helping reduce gender dysphoria” (www.untag.com).

Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. Section 510 of the Act requires domestic and foreign device establishments to submit annual establishment registration and device listing information to FDA by electronic means during the period beginning October 1st and ending December 31st of each year. Our records indicate that the binders in the UNTAG line were manufactured, prepared, propagated, compounded, or processed in an establishment that was not duly registered and were not included in a list required by section 510 of the Act. Therefore, the devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)).

The introduction or delivery for introduction into interstate commerce of these misbranded devices is a prohibited act under section 301(a) of the Act, 21 U.S.C. § 331(a).

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and injunction.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS 720843” when replying.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance. Sincerely yours,/S/Michael J. HoffmannDirectorOffice of Health Technology 3 - Gastrorenal, ObGyn,General Hospital, and Urology DevicesOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthFood and Drug Administration

cc: passionalstaff@gmail.com