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CLOSEOUT LETTER

CTX Lifesciences Private Ltd. MARCS-CMS 496393 — Oct 05, 2018

CTX Lifesciences Private Ltd. - 496393 - 10/05/2018

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