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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Greencore OARS, LLC - Close Out Letter 7/31/12

  

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

Public Health Service
Food and Drug Administration
 

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

July 31,2012


Mr. Richard Donovan
General Manager
Greencore OARS, LLC
121 Liberty Street
Brockton, MA 02301

Dear Mr. Donovan: 

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS 245116 dated December 28, 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.

Sincerely,

/S/

CAPT Mutahar S. Shamsi
District Director
New England District Office


Cc: Mr. Liam McClennon
     Chief Executive Officer
     Greencore OARS, LLC
     12 Kent Way
     Byfield, MA 01922