CTX Lifesciences Private Ltd.

CLOSEOUT LETTER CTX Lifesciences Private Ltd. MARCS-CMS 496393 — October 05, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3006254924 Recipient: Recipient Name Kanak Jariwala Recipient Title Managing Director CTX Lifesciences Private Ltd. CTX Lifesciences Private Ltd. Block No. 251-252, Sachin-Magdalla Road GIDC Sachin, Surat, Gujarat 394230 India Issuing Office: U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Mr. Jariwala: The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-17-18 issued on January 18, 2017. Based on our evaluation, it appears that you have addressed the deviations 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 FDA 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 deviations be observed during a subsequent inspection or through other means. Sincerely, /S/ LT Loan Chin Global Compliance Branch 2 Division of Drug Quality I Office of Manufacturing Quality Office of Compliance Center for Drug Evaluation and Research Content current as of: 10/30/2018