Invitrx Therapeutics, Inc

CLOSEOUT LETTER Invitrx Therapeutics, Inc MARCS-CMS 514522 — March 31, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: United Parcel Service Reference #: 17-17 Recipient: Recipient Name Mr. Habib Torfi Recipient Title CEO/President Invitrx Therapeutics, Inc 20503 Crescent Bay Dr. Lake Forest , CA 92630 United States Issuing Office: Office of Human and Animal Food Operations West Division 5 United States Dear Mr. Doe: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 17-17, dated February 27, 2017. Based on our evaluation, it appears that you have addressed the violations 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/ Sergio Chavez, Compliance Branch Director Office of Human and Animal Food Operations West Division 5 Content current as of: 04/13/2020