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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Dutch Valley Food Development Inc. 11/21/11

  

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

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
Philadelphia, PA  19106
Telephone: 215-597-4390 
 

 

WARNING LETTER
12-PHI-03
 
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
November 21, 2011
 
 
Mr. Matthew V. Burkholder, President
Dutch Valley Food Development, Inc.
7615 Lancaster Avenue
Myerstown, PA 17067
 
Dear Mr. Burkholder:
 
The Food and Drug Administration (FDA) inspected your manufacturing facility located at 7615 Lancaster Avenue, Myerstown, PA, on July 25, 2011 through August 4, 2011. 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 110). These violations cause the foods manufactured at your facility to be 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 implementing regulations on FDA’s home page www.fda.gov.
 
Specifically, our inspection of your facility revealed the following CGMP violations:
  1. In order to comply with 21 CFR 110.35(d), all food-contact surfaces, including utensils, and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food. However, on July 26, 2011 we observed:
a.  That prior to the product changeover from Coconut Macaroon Cookie mix, which contains tree nuts, wheat and egg ingredients; to All Purpose Seasoning, your firm conducted a clean in and clean out of place procedure. This procedure consisted of blowing out the (b)(4) storage (b)(4) with (b)(4) and performing a wipe down of the (b)(4) transfer pipe and (b)(4) with a wet towel, and sanitized with (b)(4).  This method of cleaning left a significant amount of white and brown food debris from the previous production run inside the (b)(4) storage hoper; on the stationary (b)(4), and outside the (b)(4) vibrator cone.
 
b.  In the bulk side production room, your firm failed to clean and sanitize shared equipment which is used daily for mixing all soups and dips containing non-allergenic and allergenic sub-ingredients. Specifically, the (b)(4), which is used to transfer mixtures form the (b)(4) hoppers into the (b)(4), and the plastic transfer chute of the (b)(4) discharge assembly; both contained extensive residual product buildup from the previous production runs.
 
c.  Numerous products containing soy, milk and wheat were previously manufactured using the (b)(4) Sifter unit. After a CIP procedure, white particulate food debris was caked on the inside of the plastic (b)(4) transfer chute, and white and brown particulate food debris was caked on the inside of the main sifter chute and bypass chute. However you proceeded to add ingredients for Pasta B Bean Tuscany, which only contains the allergens of soy and wheat.
 
d.  After a dry cleanout with (b)(4), food debris was encrusted on the inside of the (b)(4) unit which was previously used to produce cookie mix containing tree nuts. The (b)(4) unit was immediately used to be filled with Homestyle French Onion Soup mix, a soup mix which does not contain tree nuts.
 
e.  In the bulk side production room at the (b)(4) machine filling dispenser, food debris was observed on the bottom of the machine’s filling shield directly after an allergen cleanout of coconut macaroon cookie mix containing tree nuts and egg, to be used for manufacturing a meat seasoning which does not contain tree nut or egg ingredients.
 
f.  A white hand brush used for cleaning remaining powdered food debris form the sifter unit between product changeovers was stored beside a sink strainer on the stainless steel table which is connected to the sink. The brush was not cleaned or sanitized between product manufacturing changeovers.
 
g.  A which paddle used to scrape the inside on the (b)(4) was hung on the platform and was leaning on a plastic bag containing refuse.
 
h.  On July 25, 2011, food contact utensils were stored on a stainless steel rack with non-food contact surface utensils including a broom and dust pan.
 
Moreover, the production procedures your firm uses in cleaning equipment and the sequencing of production are not adequate to ensure that preceding products do not contaminate subsequent products. This is of particular concern when multiple allergenic ingredients are used to produce preceding products, and not subsequent products.
 
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 statues 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.
 
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 correct the deviations. If you can not complete all of the corrections within 15 working days, state the reason for the delay and the time within which corrections will be completed.
 
Your response should be directed to: Ms. Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, U.S. Customhouse, 2nd & Chestnut Streets, Room 900, Philadelphia, PA 19106. If you have any questions, please do not hesitate to contact Ms. Rivers at (215) 717-3076.
 
Sincerely,
/S/ 
Kirk D. Sooter     
District Director
Philadelphia District Office
 
 
cc:
 
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Assistant Director