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  5. The Smoked Goat Co Inc - 508271 - 10/24/2016
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WARNING LETTER

The Smoked Goat Co Inc MARCS-CMS 508271 —


Recipient:
The Smoked Goat Co Inc


United States

Issuing Office:
Baltimore District Office

United States


 

  

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

 

 
 
Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5707

 

 

 

WARNING LETTER
CMS# 508271
 
October 24, 2016
 
Via UPS
 
Mr. Larry F. Steelman, Owner
The Smoked Goat Co. Inc.
3529 Green Spring Road
Havre De Grace, MD 21078
 
 
Dear Mr. Steelman:
 
The Food and Drug Administration (FDA) conducted an inspection of your firm located at 3529 Green Spring Road, Havre De Grace, MD 21078 from August 12, 2016 to August 17, 2016. During the inspection, we found significant violations within the Current Good Manufacturing Practices (21 CFR 110) regulations. Accordingly, it was determined that your firm’s food products in storage are adulterated within the meaning of 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (“the Act”) [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
 
Additionally, your firm is subject to the (b)(3)(A). You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
 
Adulterated Food
 
Specifically, our inspection of your facility revealed the following violations:
 
1)  Failure to store foods under conditions and controls necessary to minimize contamination, as per 21 CFR 110.80(b)(2). During the current inspection, your firm was observed with damaged bags of products too numerous to count, identified as waste products that were commingled with human food products available for distribution.
 
2)  Failure to provide adequate screening or other protection against pests, as per 21 CFR 110.20(b)(7). During the current inspection, your firm’s second food storage container was observed with apparent rodent excreta pellets too numerous to count located near woven, permeable packages of grain. Additionally, insects too numerous to count were observed around your packaged human food products in storage.
 
3)  The plant is not constructed in a manner as to allow floors, walls and ceilings to be adequately cleaned and kept clean and kept in good repair, as per 21 CFR 110.20(b)(4). During the current inspection, your firm’s storage containers were observed to be filled with packaged food products with no access point to inspect or clean beyond approximately three feet from the entrance. Additionally, your storage containers were observed with holes on the walls and floors exposing the stored human food products to the exterior environment.
 
4)  Failure to remove litter and waste and cut weeds or grass that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, as per 21 CFR 110.20(a)(1).  During the current inspection, your firm’s storage containers of human food products were observed surrounded by uncut grass, expired animal feed, and piles of debris.
 
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your products comply with the FD&C Act and FDA’s implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice, including, without limitation, seizure or injunction. 
 
Section 743 of the FD&C 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 noncompliance materially related to a food safety requirement of the FD&C 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 noncompliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
You should respond in writing within fifteen (15) working days from your receipt of this letter.  Your response should outline the specific things you have done or plan to do to correct these violations and prevent their recurrence.  You should include in your response documentation and other useful information that would assist us in evaluating your corrections.  If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and the timeframe within which the remaining corrections will be completed. 
 
Please send your reply to the U.S. Food and Drug Administration, Attention: David P. Rice, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rice by phone at 410-779-5463 or by email at david.rice@fda.hhs.gov.
 
 
Sincerely,
/S/                                                           
Evelyn Bonnin
District Director
Baltimore District Office