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CLOSEOUT LETTER

APS BioGroup, Inc Apr 05, 2018

APS BioGroup, Inc - Close Out Letter 4/5/18


Recipient:
APS BioGroup, Inc


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
U.S. Food & Drug Administration
PO Box 25087
Denver, CO 80225
 

April 5, 2018

WARNING LETTER CLOSE-OUT

VIA UPS overnight

Mr. George Stagnitti, President & CEO
APS Biogroup, Inc.
2235 South Central Ave.
Phoenix, AZ 85004-2909

Dear Mr. Stagnitti:

The Food and Drug Administration has completed an evaluation of APS Biogroup's corrective actions in response to our Warning Letter HAF4W(DEN)-17-10-WL dated July 6, 2017. 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.

Sincerely,
/S/

LaTonya M. Mitchell
District Director, FDA Denver District
Program Division Director
Office of Human and Animal Foods - Division IV West