CLOSEOUT LETTER
U. Okada & Company, Ltd.
- Recipient:
- U. Okada & Company, Ltd.
United States
- Issuing Office:
United States
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| Food and Drug Administration San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94501-7070 Telephone: (510) 337-6700 |
Department of Health and Human Services
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
May 29, 2014
Dexter N. Okada
U. Okada & Company, Ltd.
1000 Queen Street
Honolulu, Hawaii 96814
Dear Mr. Okada:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, dated April 29, 2010. 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/
Lawton W. Lum
Director, Compliance Branch
San Francisco District