CLOSEOUT LETTER
Philadelphia 7, Inc d/b/a Passional Boutique MARCS-CMS 720843 —
- Delivery Method:
- VIA Electronic Mail
- Product:
- Medical Devices
- Recipient:
-
Recipient NameDumesh Kankanamalage
-
Recipient TitleChief Executive Officer
- Philadelphia 7, Inc d/b/a Passional Boutique
317 South St
Philadelphia, PA 19147
United States-
- manager@passionalboutique.com
- Issuing Office:
- Center for Devices and Radiological Health
United States
United States
Dear Dumesh Kankanamalage:
The Food and Drug Administration (FDA) has completed an evaluation of Philadelphia 7, Inc d/b/a Passional Boutique corrective actions in response to our Warning Letter CMS #720843, dated December 16th, 2025. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Michael J. Hoffmann
Office Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Dumesh Kankanamalage
Philadelphia 7, Inc
cc: passionalstaff@gmail.com