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U.S. Department of Health and Human Services

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Enforcement Actions

Village Cannery Of Vermont, Inc., 12/1/09

   

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

Public Health Service
Food and Drug Administration
  New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896

WARNING LETTER
NWE-08-10W

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

December 1, 2009

Mr. Joseph Sheppard, President
Village Cannery of Vermont, Inc.
698 South Barre Road
Barre, Vermont 05641

Dear Mr. Sheppard:

The Food and Drug Administration (FDA) conducted two inspections of your applesauce manufacturing facility located at 698 US Route 14, South Barre, Vermont 05760 from May 26, 2009 to June 4, 2009 and July 20, 2009 to August 4, 2009. These inspections confirmed that you manufactured and offered for sale applesauce products that were adulterated within the meaning of Sections 402(a)(1) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1) and (a)(4)].

FDA analysis of samples of applesauce processed at your facility that were collected during the inspections, revealed the presence of patulin at levels provided in the table below.

Sample # 

 

 

Product

 

 

Original Analysis
Patulin Results
(ppb)

 

 

Check Analysis
Patulin Results
(ppb)

 

493559 Organic Unsweetened
Applesauce

 

 250.7

 

 

250.3

 

557707 Organic Unsweetened
Applesauce

163.6

 

162.6

 

Patulin is a toxic substance produced by molds that may grow on apples. Your applesauce products associated with FDA Samples # 493559 and 557707, collected on May 27, 2009 and July 21, 2009 respectively, and containing the above patulin levels are adulterated within the meaning of Section 402(a)(1) [21 U.S.C. 342(a)(1)] of the Act, in that your products contain a poisonous or deleterious substance which may render the products injurious to health.

The inspections found serious deviations from the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulation, Title 21, Code of Federal Regulations ( CFR), Part 110 (21 CFR 110). Therefore, your applesauce products are also adulterated within the meaning of Section 402(a)(4) of the Act [21 USC 342(a)(4)], in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.

Your significant violations are as follows:

1. To comply with 21 CFR 110.80(a)(1), you must ensure raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food. However, your firm’s culling practices observed during the manufacturing operation of applesauce were not adequate to segregate and clean raw materials to eliminate visibly moldy, rotten, or damaged fruit. Your firm's practice of removing apples from a conveyor belt and rinsing apples is not adequate to remove apples with rot.

2. To comply with 21 CFR 110.35(d)(2), you must clean all food-contact surfaces, including utensils and food-contact surfaces of equipment, as frequently as necessary to protect against contamination of food. However, your firm did not use detergent or sanitizer to clean equipment used to manufacture applesauce, and dried apple pumice was observed on the outside of the steel steam jacketed kettles after the kettles were scrubbed with water and a scouring pad.

3. To comply with 21 CFR 110.37(b)(3), plumbing shall be adequately installed and maintained to avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition. However, your firm's hand washing and compartment sinks drain directly to the floor, and equipment used during the manufacturing of applesauce was observed on the floor in close proximity to the hand washing sink drain outlet.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and applicable regulations.

Failure to implement lasting corrective action of these violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.

We request that you notify this office in writing, within 15 working days from your receipt of this letter, of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.

Please send your reply to the Food and Drug Administration, Attention: Attention: Lori A. Holmquist, Compliance Officer, 330 Civic Center Drive, Suite 1, Box 4, Augusta, Maine 04330. If you have questions regarding any issues in this letter, please contact Ms. Holmquist at 207.622.8268 x 13.

Sincerely,

/s/

John R. Marzilli
District Director
New England District


Cc: Mr. Kenneth Davis, Vice President of Operations
Village Cannery of Vermont, Inc.
698 South Barre Road
Barre, Vermont 05641