Inspections, Compliance, Enforcement, and Criminal Investigations

QL FIGO FOODS SDN BHD 11/5/14

  

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

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

NOV 5, 2014

WARNING LETTER
 
 
VIA EXPRESS DELIVERY
 
Mr. Lee Teck Wee
Executive Director
QL Figo Foods SDN BHD
Lots 23 & 25 Jalan Perdayangan 16
Taman University Industrial Park
Skudai, Johor Bahru, 81100 Malaysia
 
Reference No. 440043
 
Dear Mr. Lee Teck Wee:
 
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility QL Figo Foods SDN BHN located at Lots 23 & 25 Jalan Perdayangan 16, Taman University Industrial Park, Skudai, Johor Bahru, Malaysia, on May 21 and 22, 2014. During that inspection, we found that you had violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the observations made at your firm. 
 
We acknowledge receipt of your response sent via email dated on June 3, 2014. Your response included three revised HACCP plans:
  • “IQF fish, Cuttlefish, Prawn Cuttlefish, Vegetable Cuttlefish, Chicken & Beef Ball”
  • “IQF Thai fish cake, pumpkin fish balls, vegie fried fish cake, fried fish cake, fried fish ball/bar, scallop shape seafood tofu, golden seafood nugget, seafood tofu, cheese seafood tofu”
  • “IQF lobster flavored ball”
Review of these plans revealed serious deviations from the seafood HACCP regulation, 21 CFR Part 123. 
 
In addition, during the inspection, FDA collected labels for many of your products. We also have performed a labeling review and have identified serious deviations from the FDA’s labeling and color additive requirements. 
 
SEAFOOD HACCP
 
In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123 renders the fish or 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 fish balls, cuttlefish balls, seafood tofu, prawn cuttlefish balls, golden crab nugget, lobster balls (surimi) products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
 
You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at www.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm.
 
Your significant deviations are as follows:
 
1.    You must conduct or have conducted for you 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 three revised HACCP plans provided with your June 3, 2014, response do not list the food safety hazard of Clostridium botulinum growth and toxin formation.
 
Your individually quick frozen (IQF) products are packaged in an oxygen impermeable material and vacuum sealed, which creates an environment conducive to Clostridium botulinum growth and toxin formation under certain abusive conditions. Once your firm identifies the hazard, we recommend that you include a critical control point in each plan to ensure each batch of labels includes instructions for handling to ensure that the products are not exposed to time and temperature abuse. For example we recommend that each label include instructions such as “Keep Frozen,” “Important Thaw Under Refrigeration Immediately Before Use” or similar instructions to ensure that the end user handles the product appropriately.  
 
2.    You must conduct a hazard analysis 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 critical control points to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s three revised HACCP plans provided with your June 3rd response do not list a critical control point for cooling to control post cook pathogen growth and toxin formation as a result of time/temperature abuse. 
 
Once included as a critical control point, FDA recommends that for products held at internal temperatures above 26.6°C/80°F, exposure time to temperatures above 10°C/50°F should be limited to four (4) hours, as long as no more than one (1) of those hours is above 21.1°C/70°F.  FDA also recommends that you monitor the length of the cooling cycle and the internal temperature of the products (at least until the products enter the freezer) or the critical factors of the process that affect the rate of cooling, as established by a cooling rate study. These critical factors may include the processing room temperature and the amount of time that the product is exposed to this temperature prior to being place in the freezer. 

3.    You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4). However, your firm’s three revised HACCP plans provided with your June 3rd response list monitoring procedures/frequencies at the following critical control points that are not adequate:  
 
a.    At the cooking and frying critical control points, the monitoring procedures/frequencies are not adequate to control pathogen survival though cooking. Your plans list that you will monitor 2 samples per batch; however, this does not ensure that each piece of fish product in the batch receives an adequate scheduled cook. Because your firm is monitoring end-point internal product temperatures using continuous cooking apparatus, FDA recommends monitoring the end-point internal product temperature at least every 30 minutes. 
 
b.    At the allergen critical control points, the monitoring procedures/frequencies are not adequate to control undeclared allergens.  Your plan lists that you will monitor each label design before sending to final printing; however, this does not ensure that the correct labels with the correct corresponding allergenic ingredients are applied to the correct corresponding product. Because you package a variety of products manufactured with different allergenic ingredients, FDA recommends that you visually examine the labels on finished product packages for comparison with the product formulation from a representative number of packages from each lot of finished product.
 
The allergen critical control point (i.e., CCP No. 6) in the plans needs to identify the point at which this step is performed.  For example, FDA recommends a review at the finished product labeling step.
 
4.    Corrective action plans when included in HACCP plans must be appropriate, to comply with 21 CFR 123.7(b).   However, your corrective actions at the cooking and frying critical control points are not appropriate.  Specifically, your listed actions of “isolate affected product and reject” do not ensure that potentially adulterated products do not enter into commerce.  FDA recommends that you destroy the product, divert the product to a non-food use, or recook the product.
  
FOOD LABELING AND COLOR ADDITIVES
 
1.    Your Dragonfly Prawn Cuttlefish Balls and Dragonfly Cuttlefish Ballsproducts are misbranded within the meaning of Section 403(w) of the Act, [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergen eggs as required by section 403(w)(1) of the Act.
 
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils as “major food allergens.” A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
 
o    The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or
 
o    The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].
 
Specifically, your Dragonfly Cuttlefish Balls and Dragonfly Prawn Cuttlefish Balls products are manufactured using frozen egg whites, which contains eggs.
 
2.    Your Dragonfly Prawn Cuttlefish Balls product is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because it contains color additives that are unsafe within the meaning of section 721(a) of the Act. For example, according to the product formulation, the product is manufactured using Sunset Yellow FCF (C.I. 15985, certifiable as FD&C Yellow No. 6) that does not appear to have originated from a certified batch; and the product also contains non-permitted Ponceau 4R (C.I. 16255).
 
3.    Your Dragonfly Fish Balls, Dragonfly Prawn Cuttlefish Balls, and Dragonfly Cuttlefish Balls products are misbranded within the meaning of Section 403(q)(1) of the Act [21 U.S.C. § 343(q)(1)] in that the serving sizes are not expressed using the reference amount customarily consumed (RACC) that is appropriate to the food as defined within 21 CFR 101.12. The appropriate RACC for these products is 85 g and the serving size is the number of pieces closest to 85 g followed by the metric weight. Your products list a serving size of 30g.
 
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 deviations.  More specifically, your response should include a copy of any revised labels; documentation reflecting the changes you made to your HACCP system, such as a copy of your revised HACCP plan, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan; and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the FDA requirements.  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 or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported 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.  An example of an Import Alert that conveys information specific to foreign firms that are not in compliance with color additive regulations is Import Alert #45-02.   You may view these alerts at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
 
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 re-inspection-related costs.  A re-inspection is 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.  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 foreign facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
 
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation, the Good Manufacturing Practice regulation (21 CFR 110), and the food labeling regulations.  You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
In addition, we have the following labeling comments:
  • Your Dragonfly Fish Balls and Dragonfly Prawn Cuttlefish Balls products are labeled to contain the ingredient “Surimi,” which is not the common or usual name of the ingredient. 
  • The formulation sheet for your Dragonfly Cuttlefish Balls product indicates that the product is manufactured using the ingredients “vegetable protein,” “edible oil,” “Activa (TG)”; however, you fail to list these ingredients on your finished product label. These are not the appropriate common or usual names for these ingredients; therefore, if you change your labels to include these ingredients, the revised ingredient statement must include the correct common or usual names for the ingredients.
  • Your product labels for your Dragonfly Fish Balls, Dragonfly Prawn Cuttlefish Balls, and Dragonfly Cuttlefish Balls products list “Bigeye (Lutjanus lujanus)”; however, the correct common name for the species Lutjanus lujanus is Snapper. 
Please send your reply to the U.S. Food and Drug Administration, Attention: Catherine Vieweg, Compliance Officer, 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 #440043 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, Jr.
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition

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