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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Well – Delight Network Corporation 7/20/12


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

Public Health Service
Food and Drug Administration

College Park, MD  20740

JUL 20, 2012



Ms Emma R. Garay
Well – Delight Network Corporation
China Building, Refrigeration Plant B
General Santos City

Reference No.: 320138

Dear Ms. Garay:

This letter is in response to the documentation your firm provided on April 16, 2012, in response to the request by the U.S. Food and Drug Administration (FDA) for copies of your firm’s most recent HACCP plans, monitoring records, hazard analysis and product flow diagrams.  We have evaluated the information provided in your April 16th submission and have found concerns with your HACCP program, which are further explained in this letter.  

Failure of a processor to have and implement a HACCP plan that complies with 21 CFR 123.6(g), or otherwise in accordance with the requirements of 21 CFR part 123, renders the fishery products 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)].  Accordingly, your firm’s fresh and frozen tuna appear to be adulterated, in that the products have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulation through links in FDA’s home page at www.fda.gov.

Your firm’s significant deviations from the requirements of the Seafood HACCP regulation are as follows:

1. You must conduct a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that at a minimum lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as, “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.”  However, your firm’s HACCP plan for fresh and frozen tuna does not list the food safety hazards of Clostridium botulinum growth and toxin formation and undeclared allergens. 

a. Your firm mentions in your hazard analysis that you will control Clostridium botulinum growth and toxin formation with (b)(4); however, the hazard is not identified in your HACCP plan. With regard to the hazard of Clostridium botulinum, your product description includes references to vacuum package IVP packaging and carbon monoxide treatment. Vacuum packaging creates a potential for Clostridium botulinum even for frozen products because toxin may develop during thawing. FDA recommends that firms ensure that statements on the labels of the frozen products include, “keep frozen” and “Important, Keep Frozen and Thaw Under Refrigeration Immediately Prior to Use.”

In addition, the carbon monoxide treatment is conducted under anaerobic conditions for an extended time period (described in your documentation as (b)(4). This extended time period under anaerobic conditions creates an environment conducive to toxin formation. FDA recommends that the carbon monoxide treatment be conducted at temperatures below 3.3° C (38° F), which are monitored continuously with a temperature recording device.

b. With regard to the hazard of undeclared allergens, once identified as a hazard, FDA recommends that firms include a critical control point in their HACCP plans to ensure the finished product is accurately labeled with the market name of the fish. 

2. You must have a HACCP plan that, at a minimum, lists a critical limit that must be met, to comply with 21 CFR 123.6(c)(3).  A critical limit is defined in 21 CFR 123.3(c) as, “the maximum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.”  However your firm’s HACCP plan for frozen tuna does not list adequate critical limits at the “Receiving” CCP to control scombrotoxin formation. 

With regard to sensory evaluation, this element as part of the HACCP program for a primary processor is intended to assess the condition of the lot of fish at receiving, but your plan does not list a value that will cause the lot to be rejected or examined more closely for safety defects.  FDA recommends that firms conduct sensory examination on a representative sample of scombrotoxin-forming fish and that firms take an appropriate corrective action when 2.5 % or more of the fish in the sample exhibit decomposition.  Your plan indicates that you will assess all the fish. Although you may be excluding individual decomposed fish, you should also be evaluating the lot as a whole to determine if there are potentially unsafe conditions that caused the fish to be decomposed.  

In addition, we note that your monitoring record qualifies decomposition into (b)(4) and (b)(4). You should be aware that FDA considers fish that exhibit persistent odors of decomposition objectionable. 

3. Predetermined corrective action plans included in the firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). However, the corrective action listed at the “Chilling” critical control point, is not appropriate.

At the “Chilling” critical control point, your listed corrective action indicates that action is not taken until the product temperature is (b)(4) however, your critical limit is listed as “Chiller Room must be maintained (b)(4) at this same critical control point. Because your firm is monitoring the chiller room temperature and not the product temperature, you will not have the parameters associated with product temperatures on which to base the need to take a corrective action. For your information, FDA does not consider the internal temperature of stored products an adequate indicator of product safety. We recommend evaluating the time and ambient temperature of the chiller room via the continuous temperature monitoring record to assess the total time and temperature exposures above the listed temperature critical limit (b)(4)

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation, such as: a copy of any revised HACCP plans; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen days, you should explain the reason for your delay and state when you will correct any remaining violations. Providing the documents in English will help in our review.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your fish or fishery 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 seafood HACCP regulation is Import Alert #16-120. This alert can be found on FDA’s web site at:  http://www.fda.gov/ora/fiars/ora_import_ia16120.html

Please send your reply to the Food and Drug Administration, Attention: Carol D’lima, Compliance Officer, CFSAN Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Carol.Dlima@fda.hhs.gov.  Please reference FEI #3009032605 on any submissions and within the subject line of any emails to us.  You may also contact Carol D’lima at (240) 402-2033 or email if you have any questions about this letter. 



Michael W. Roosevelt 
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition