Philadelphia 7, Inc d/b/a Passional Boutique

CLOSEOUT LETTER Philadelphia 7, Inc d/b/a Passional Boutique MARCS-CMS 720843 — March 27, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Dumesh Kankanamalage Recipient Title Chief 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 Secondary Issuing Offices 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 Content current as of: 04/06/2026 Regulated Product(s) Medical Devices