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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Braintree Laboratories, Inc. Close out Letter 4/27/11

  

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

Public Health Service
Food and Drug Administration
 

New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 587-7500
FAX: (781) 587-7556 


April 27, 2011


Mr. Harry P. Keegan
President/ Owner
Braintree Laboratories, Inc.
60 Columbian Street
Braintree, MA 02185


Dear Mr. Keegan:


The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated May 10, 2010 (NWE-17-10W) during an inspection of your facility on December 30, 2010 – January 21, 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 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.


If you have any further questions, please feel free to call me at 781-587-7491.


Karen Archdeacon
Compliance Officer
New England District