Inspections, Compliance, Enforcement, and Criminal Investigations

A & M Bakery, Inc. - Close Out Letter 1/30/15

  

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

 
 Food and Drug Administration
Baltimore District Office
Central Region
6000 Metro Drive
Baltimore, MD 21201-2199
Telephone: (410) 779-5455
FAX: (410) 779-5705

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


January 30, 2015


Mr. Michael W. Harris and Mrs. Pamela J. Harris, Co-Owners
A & M Bakery
128 South 3rd Street
Clarksburg, WV, 26301


Dear Mr. & Mrs. Harris,

The Food and Drug Administration issued a Warning Letter (#395943) dated April 23, 2014 to your firm. The Warning Letter was issued as a result of significant observations identified from the inspection concluded March 27, 2013.

Your most recent inspection was completed October 30, 2014 and noted that the previously identified observations that resulted in the issuance of the Warning Letter have been corrected. 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/

CDR Rochelle B. Young, RPh, MSA
Compliance Officer, Baltimore District Office

Page Last Updated: 02/03/2015
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