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WARNING LETTER

Dutchman's Bakeshop, LLC


Recipient:
Dutchman's Bakeshop, LLC


United States

Issuing Office:
Baltimore District Office

United States


  

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

Public Health Service
Food and Drug Administration
 
Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707

**WARNING LETTER**

CMS# 449931

 

February 3, 2015
 
Via UPS
 
Mr. Jean M. Scheeren, Owner
Dutchman’s Bakeshop, LLC
1300 Hopeman Parkway
Waynesboro, VA 22980-1950
 
Dear Mr. Scheeren:
 
We inspected your firm, a manufacturer of ready-to-eat ice cream cones, located at 1300 Hopeman Parkway in Waynesboro, VA 22980-1950 between November 3 and November 12, 2014. The inspection found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations in manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These CGMP violations cause the food manufactured at your facility to be considered adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on FDA’s home page  www.fda.gov.
 
Specifically, our inspection of your facility revealed the following CGMP violations:
 
1.)    Your firm failed to take effective measures to exclude pests from processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, our investigators observed numerous incidences of apparent insects and apparent rodent excreta pellets throughout your Production Area, including your general work area, storage room #1, storage room #2, dishwashing room, ingredient mixing room, and storage room #3.
 
We acknowledge that you voluntarily agreed to destroy approximately (b)(4) of finished product manufactured and/or purchased by your firm due to the apparent insect activity on November 4, 2014. However, we are concerned with your continued inability to take effective measures to exclude pests since this same issue was cited during our previous inspection which ended July 17, 2013.  In addition, inspections conducted by the Virginia Department of Agriculture and Consumer Services (VDACS) have also noted repeated instances of apparent insect and apparent rodent activity.
 
2.)    Your firm failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically, our investigators observed gaps around exit doors located in the Production Area, around an exit door in Bay #1, and around loading dock doors in Bay #3.
 
We are concerned with your continued inability to adequately address and prevent gaps in your facility that could allow pests to enter. This same deficiency was cited during our previous inspection which ended July 17, 2013 and also during repeated inspections by VDACS personnel.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA.  You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products and/or injunction.
 
Furthermore, Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection- related costs.
 
We request that you notify this office in writing, within fifteen (15) working days of receipt of this letter. Your response should include the specific steps you have taken to prevent these violations from recurring.  If you can not complete this within 15 working days, state the reason for the delay and the time within which these actions will be completed.
 
Your response should be directed to: Mr. Ernest F. Bizjak, Compliance Officer, U.S. Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, MD 21215.  If you have any questions, please do not hesitate to contact Mr. Bizjak by calling (410)779-5715 or sending an email to ernest.bizjak@fda.hhs.gov.
 
 
Sincerely yours,
/S/
Theresa Smedley
Acting District Director
Baltimore District Office
 
CC:
Lisa P. Ramsey, MS
VDACS Office of Dairy and Foods
Food Safety Regional Manager, Southwest
2943-E Peters Creek Road
Roanoke, VA   24019