Novacyl (Thailand) Ltd.

CLOSEOUT LETTER Novacyl (Thailand) Ltd. MARCS-CMS 433932 — May 17, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Novacyl (Thailand) Ltd. United States Issuing Office: United States 10903 New Hampshire Avenue Silver Spring, MD 20993 May 17, 2018 Barnabe Chaize, Managing Director 321 Moo, Bangpoo Industrial Estate Soi 6 B Praeska, Muang, Samutprakam, 10280 Thailand Reference: FEI 3000287096 Dear Mr. Chaize: The Food and Drug Administration (FDA) has completed an evaluation of your firm 's corretive actions in response lo our Warning Letter: #320-15-07 dated February 27, 2015. Based on our evaluation, it appears that you have addressed the deviations contained in th is Warning Letter. Future FDA inspections and rcgulutory activities will further assess the adequacy and sustainability or these correct ions. 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 stale 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/ Bryce Hammer Compliance Officer Division of Drug Quality II Content current as of: 06/06/2018