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  5. West Food Company - 10/02/2014
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WARNING LETTER

West Food Company


Recipient:
West Food Company


United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

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

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

 

WARNING LETTER
OCT 2, 2014 
 
VIA EXPRESS DELIVERY
 
Ms. Le Kim Loan, Director
West Food Company
Cai Son Hang Bang Industrial Zone
An Binh Ward, Ninh Kieu District
Can Tho, Vietnam
 
 
Reference No. 437687
 
Dear Ms. Le Kim Loan:
 
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) and acidified food facility located at Cai Son Hang Bang Industrial Zone, An Binh Ward, Ninh Kieu District, Can Tho, Vietnam on March 27th to 30th, 2014. During that inspection, we found that your firm had serious deviations from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR 108)), the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113), and the Acidified Foods regulation (21 CFR 114). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, which lists the serious deviations found at the firm. We acknowledge receipt of your firm’s responses to the FDA-483 received on April, 18, 2014 and May 21, 2014; however, our evaluation of the documentation revealed that the responses were not adequate, as further described in this letter.
 
As a manufacturer of thermally processed low-acid foods and acidified food products intended for export into the United States, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act), and all applicable federal regulations. Regulations specific to the processing of acidified foods are described in 21 CFR 108, Emergency Permit Control, 21 CFR 113,  Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers and 21 CFR 114, Acidified Foods. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25, 21 CFR 108.35, 21 CFR 113, and 21 CFR 114 could be subjected to an immediate application of the emergency permit control provisions of Section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.25(j) and 21 CFR 108.35(k), for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. Violation of the mandatory requirements set forth in 21 CFR 108.25, 21 CFR 108.35,21 CFR 113, and 21 CFR 114 renders your LACF and acidified food products adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).
 
You can find the Act and the LACF and acidified food regulations through links in FDA’s home page at www.fda.gov.
 
Your significant violations are as follows:
 
1.    Your firm failed to process each acidified foods in conformity with at least the scheduled process as required by 21 CFR 108.25(c)(3)(i). Specifically, your firm’s scheduled processes for tropical fruit salad (cocktail) in syrup (b)(4). However, our inspection revealed your firm has been heat processing this product at (b)(4)
 
Your response received May 21, 2014 states that your firm is now processing according to the schedule process; however, no processing records demonstrating process adherence were received. 
 
2.    Your firm failed to obtain substantiation by a qualified scientific authority as to the adequacy of any intentional change in a previously filed scheduled process and you failed to submit to FDA, within 30 days after first use, a complete description of the modifications made and utilized, as required by 21 CFR 108.35(c)(2)(ii). Specifically, your firm made changes to the retort time and temperature in the scheduled process for your baby corn, whole, in brine (SID 2005-07-25/005) and baby corn, cuts, in brine (SID 2005-07-25/006) without substantiation by a qualified scientific authority and did not report the changes to the FDA within 30 days after first use.  Your firm’s filed scheduled processes for your baby corn, whole, in brine and baby corn, cuts, in brine state that the sterilization temperature is (b)(4). However, our inspection revealed your firm has been sterilizing these products at (b)(4)
 
Your response received May 21, 2014 states that your firm is now processing according to the schedule process; however, no processing records demonstrating process adherence were received. 
 
3.    Your firm failed to process each low-acid canned food in conformity with at least the scheduled process as required by 21 CFR 108.35(c)(3)(i).  Specifically, your firm’s filed scheduled processes for your baby corn, whole, in brine and baby corn, cuts, in brine state that the sterilization temperature is (b)(4).  However, our inspection revealed your firm has been sterilizing these products at (b)(4).  
 
Your response received May 21, 2014 states that your firm is now processing according to the schedule process; however, no processing records demonstrating process adherence were received. 
 
4.    Your firm failed to have each retort equipped with at least one temperature-indicating device that accurately indicates the temperature during thermal processing as required by 21 CFR 113.40(a)(1). Specifically, during the inspection, our investigator observed your (b)(4) used for your LACF products were fitted with a (b)(4); however, your firm used the (b)(4) as a reference thermometer to indicate the processing temperature.  The recording thermometer was observed to read higher than the (b)(4) and reached cook temperature during come-up time faster than the (b)(4)
 
Your response received May 21, 2014 states that your firm is now using a calibrated (b)(4); however, no supporting documentation was received.  
 
5.    Your firm's process timing began before the retort was properly vented and the processing temperature was reached as required by 21 CFR 113.40(a)(12).  Specifically, our inspection found that the processing authority recommended a vent schedule of at (b)(4).  However, in practice, your firm vents for (b)(4) when processing the baby corn in brine (whole and cuts).  
 
Your response received May 21, 2014 states that your firm is now processing according to the schedule process; however, no supporting documentation was received.  
 
6.    Your firm failed to establish scheduled processes of your acidified foods in accordance with 21 CFR 114.83. Specifically, you do not have scheduled processes established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods, as required by 21 CFR 114.83 for your firm’s acidified food tropical fruit salad (cocktail) in syrup. 
 
Your response received May 21, 2014 states your firm is pursuing a review of the process by a scientific authority. Your firm attempted to file new scheduled processes (b)(4) for your tropical fruit salad (cocktail) in syrup products; however, these process filings were returned because the forms were missing the Least Sterilizing Value and a list of ingredients and are therefore not considered to be filed with the FDA.
 
7.    Your firm failed to fully reprocess, thermally reprocess as a low-acid food under 21 CFR 113, or set aside for further evaluation as to any potential public health significance a portion of food which deviated from a scheduled process, as required by 21 CFR 114.89. Specifically, your firm’s scheduled processes for tropical fruit salad (cocktail) in syrup (b)(4) states that the sterilization is (b)(4). However, our inspection revealed your firm has been heat processing this product at (b)(4) to preserve the crunchiness of corn and fruits in the finished products.  Your firm did not use a processing authority to evaluate or establish this new procedure but instead processed two pilot batches and performed microbial analysis on two finished cans of each batch. Negative microbial analytical findings do not substitute for the review and approval of process changes by a processing authority and filing of any process change with the FDA.
 
Your response received May 21, 2014 states that your firm is now processing according to the schedule process; however, no processing records demonstrating process adherence were received.  
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations and should include documentation that would assist us in evaluating your corrections. Responding in English will help to assist us in our review of your documentation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
 
If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported LACF and acidified food products under Section 801(a) of the Act, 21 U.S.C. 381(a), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the LACF and acidified food regulations (21 CFR 108, 113, and 114) is Import Alert #99-38. This alert can be found on FDA’s web site at: www.accessdata.fda.gov/cms_ia/ialist.html.
 
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 all applicable regulations, including the Acidified Food regulations (21 CFR 108 and 114), the LACF regulation (21 CFR 113), and the Good Manufacturing Practices regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Additionally, 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 reinspection related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Catherine Vieweg, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Catherine.Vieweg@fda.hhs.gov. Please reference #437687 on any submissions and within the subject line of any emails to us. You may also contact Catherine Vieweg via email if you have any questions about this letter. 
 
Sincerely,
/S/ 
William A. Correll 
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition

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