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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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IriSys, Inc. - Close Out Letter 9/24/12

  

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

Public Health Service
Food and Drug Administration
 

Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

September 24, 2012

Gina M. Stack
President/CEO
IriSys, Inc.
8810 Rehco Rd., Suite F
San Diego, CA 92121-3262

Dear Ms. Stack:  

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, W/L 41-10, dated August 19, 2010. Based on our evaluation, it appears that you have addressed the violations 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 the 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 the firm to maintain compliance and will continue to monitor their 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/

Blake Bevill
Director, Compliance Branch
Los Angeles District Office