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CLOSEOUT LETTER

Fresenius Kabi USA, LLC Jul 26, 2017

Fresenius Kabi USA, LLC - Close Out Letter 7/26/17


Fresenius Kabi USA, LLC

 

  

Black HHS-Blue FDA Logo

 

Division of Pharmaceutical Quality Operations I
10 Waterview Blvd, 3rd FL
Parsippany, NJ 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969

 
 

July 26, 2017

John Ducker, President
Fresenius Kabi USA, LLC
Three Corporate Drive
Lake Zurich, Illinois 6004 7

Dear Mr. Ducker:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [NYK-2012-14 dated February 22, 2012]. Based on our evaluation, it appears that you have addressed the violation(s) 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 Agency 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 violations be observed during a subsequent inspection or through other means.


/S/
CDR Frank Verni, R.Ph.
Compliance Officer
U.S. Food and Drug Administration
New York District Office
Pharmaceutical Quality I Compliance Branch (PHRMl-CB)

cc (via email):
 

• Michael Schonhofen, President, Phannaceutical Division
• Steve Nowicki, Senior Vice President - Global Operations North America
• Anne Huffman, Vice President, Quality Assurance - Plant Operations
 

Office of Pharmaceutical Quality Operations. Division of Pharmaceutical Quality Operations I
New England District Office: One Montvale Avenue, 4th Floor Stoneham, MA 02180-3500
T- (781) 587-7500 F- (781) 587-7556

New York District Office: 158-15 Liberty Ave Jamaica, NY 11433
T-(718) 340-7000 F-(718) 662-5661

Philadelphia District Office: US Customs House Room 900, 200 Chestnut St. Philadelphia, PA 19106
T- (215) 597-4390 F-(215) 597-4660

Baltimore District Office: 6000 Metro Drive, Suite 101 Baltimore, MD 21215
T-410-779-5455 F- 410-779-5407