Novacyl (Thailand) Ltd. - Close Out Letter 5/17/18
- Novacyl (Thailand) Ltd.
- Issuing Office:
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.
Division of Drug Quality II