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CLOSEOUT LETTER

Corden Pharma Latina S.p.A. Aug 17, 2017

Corden Pharma Latina S.p.A. - Close Out Letter 8/17/17


Corden Pharma Latina S.p.A.

 

  

Black HHS-Blue FDA Logo

 

 

 
10903 New Hampshire Avenue
Silver Spring, MD 20993 

August 17, 2017

Emilio Frongia, Managing Director
Corden Pharma S.p.A
Via del Murillo Km 2800
Sermoncta, Latina, Italy, 04013

Reference: FEI 3001229385

Dear Emilio:

The Food and Drug Administration (FDA) has completed an evaluation of your firm 's corrective actions in response to our Warning Letter: 320-16-14 dated May 20, 2016. Based on our evaluation, it appears that you have addressed the violations and/or deviations contained in this Warning Letter. Future FDA inspections and regulatory activities will fu rther 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 with current good manufacturing practices and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations and/or deviations be observed during a subsequent inspection or through other means.

Sincerely,

/S/
Matthew Schnupp
Compliance Officer
Division of Drug Quality II