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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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United Contact Lens, Inc. - Close Out Letter 2/22/12

  

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

Public Health Service
Food and Drug Administration
 

Seattle District
Pacific Region
22201 23rd Drive St:
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996
 

February 22, 2011

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Neal R. Cook, President
United Contact Lens, Inc.
19111 61st Avenue NE, Unit 5
Arlington, Washington 98223

Dear Mr. Cook:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter SEA 11-23 issued to you on September 9, 2011. 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 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 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/

Charles M. Breen
District Director

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