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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Paragon DX, LLC - Closed Out Letter 5/11/10

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
Document Mail Center - W066-0609
Silver Spring, MD 20993-0002

 

May 11, 2010

 

 

VIA UPS EXPRESS

Kenneth G. Butz
Vice President, Product Development & Manufacturing
Paragon Ox, LLC
133 Southcenter Court, Ste 200
Morrisville, NC 27560

Dear Mr. Butz:

The Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Device and Radiological Health has received your letter dated April 6, 2010. Your letter was in response to a Warning Letter dated March 18, 2010 from the Food and Drug Administration. We have reviewed your responses and corrections appear to be adequate at this time. These corrections will be verified during the next scheduled inspection.

Your response indicated that the below corrections were made:

1) Discontinued the sale (as Analyte Specific Reagents) of the following products referenced in the letter:

 

Catalog No.Gene/AlleleDescription
A-003-02PB

CYP2C9*2

(Wild Type/Mutant)

ASR Probe Mix

(5' FAM/F' CAL Fluor Orange 560)

A-003-03PB

CYP2C9*3

(Wild Type/Mutant)

ASR Probe Mix

(5' Quasar 670/F' CAL Fluor Red 610)

A-004-173PB

VKORC1 1173

(Wild Type/Mutant)

ASR Probe Mix

(5' FAM/F' CAL Fluor Orange 560)

A-004-3730PB

VKORC1 3730

(Wild Type/Mutant)

ASR Probe Mix

(5" Quasar 670/F' CAL Fluor Red 610)


2) Informed customers that ParagonDx will discontinue sale (as Analyte Specific Reagents) of the referenced reagents.

3) Initated a CAPA plan that covers items 1 and 2 as well an overall corporate compliance plan for the future development and manufacture of products.

Sincerely,

/s/


James L. Woods,
Deputy Director, Product Safety and
Product Quality
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and Radiological Health