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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Gibson Laboratories Close out Letter 8/4/10

 

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

Public Health Service
Food and Drug Administration
 Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771 

August 4, 2010


Naomi Bowling
Vice President and General Manager
Gibson Laboratories
1040 Manchester Street
Lexington, KY 40508


Dear Ms. Bowling:


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # CIN-10-82745-01, dated November 3, 2009. 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/
Toniette K. Williams
Director, Compliance Branch
Cincinnati District


Cc: Robert White, CEO
Gibson Laboratories, LLC
217 Osseo Avenue North
St. Cloud, MN 56303