Inspections, Compliance, Enforcement, and Criminal Investigations

Tentay Food Sauces, Inc. 4/19/16

  

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
APR 19, 2016 
 
VIA EXPRESS DELIVERY
 
Mrs. Velia J Cruz, President and CEO
Tentay Food Sauces
#46 Los Martirez Street
San Jose
Navotas, 1485 Philippines
 
Reference No.: # 492219
 
Dear Mrs. Cruz:
 
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility,  Tentay Food Sauces, located #46 Los Martirez Street San Jose, Navotas, 1485 Philippines on September 8-9, 2015. 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 on October 28, 2015 and January 5, 2016. Your response October 28, 2015, included Histamine Test Kit Photos and proof of purchase. Your response January 5, 2016, included a corrected HACCP Plan for your Fish Sauce product and a document entitled, “Histamine Results of Fish Sauce from Fermentation Tanks.” However, review of the documentation revealed that the response was not adequate, as further described in this letter.
 
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 sauce 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 HACCP plan for Fish Sauce does not list the food safety hazard of Clostridium botulinum toxin formation. As the material used to make the product is (b)(4), FDA recommends that your firms’ HACCP plans include controls for pre-formed Clostridium botulinum toxin that is reasonably likely to occur in the raw material used to make the product and for Clostridium botulinum toxin that is reasonably likely to occur in the finished product. To control pre-formed Clostridium botulinum toxin, FDA recommends adding a boiling step (critical control point) to your process prior to filling and boiling the product at 100°C for 10 minutes.
 
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 HACCP plan for Fish Sauce does not list the critical control points of storage (prior to unrefrigerated processing) and unrefrigerated processing for controlling the food safety hazard of scombrotoxin (histamine) formation. FDA recommends that the following critical limits be established at these critical control points:
 
a.  For refrigerated (not frozen) storage of raw material, in-process product, or finished product:
  • The product is held at a cooler temperature of 40°F (4.4°C) or below.
OR
 
b.  For raw material, in-process product, or finished product stored under ice:
  • The product is completely and continuously surrounded by ice throughout the storage time.
AND
 
c.  During processing (e.g., butchering, cleaning, brining, salting, smoking, drying, fermenting, pickling, mixing, fermenting, stuffing, packing, labeling, and staging) of scombrotoxin-forming fish that have not been previously frozen or heat processed sufficiently to destroy scombrotoxin-forming bacteria:
  • The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 4 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C);
OR
  • The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 8 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C).
Please note: Time and temperature of exposure controls during processing are necessary until the product has achieved a water phase salt level of at least 20% or a water activity of 0.85 or below.
 
3.    You must have a HACCP plan that, at a minimum, lists the critical limits 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 or minimum 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 Fish Sauce lists critical limits, at the “Receiving” critical control point, that are not adequate to control the food safety hazard of scombrotoxin (histamine) formation. Specifically, the critical limits do not ensure that appropriate harvesting and onboard practices were used onboard the harvest vessel. FDA recommends that, in addition to critical limits for histamine testing and sensory examination, your firms’ HACCP plans include a critical limit(s) for the internal temperature of a representative number of the largest fish in the lot, at the time of off-loading from the harvest vessel by the processor, as follows:
 
a.  For fish held iced or refrigerated (not frozen) onboard the vessel from 15 to less than 24 hours after death:
  • The internal temperature should be 40°F (4.4°C) or below;
OR
 
b.  For fish held iced or refrigerated (not frozen) onboard the vessel from 15 to less than 24 hours after death:
  • The internal temperature should be 50°F (10°C) or below;
OR
 
c.  For fish held iced or refrigerated (not Frozen) onboard the vessel from 12 to less than 15 hours after death:
  • The internal temperature should be 60°F (15.6°C) or below;
OR
 
d.  For fish held iced or refrigerated (not frozen) onboard the vessel less than 12 hours after death:
  • The internal temperature should be sufficiently below water and air temperatures to indicate that appropriate chilling methods were implemented onboard the harvest vessel. Chilling of the fish should begin on the harvest vessel regardless of the time from death until off-loading from the vessel by the processor, unless the environmental conditions (e.g. air and water temperatures) are below 40°F (4.4°C) from the time of death until off-loading from the vessel by the processor;
OR
 
e.  For fish held iced or refrigerated (not frozen) onboard the vessel:
  • Elapsed time from death and internal temperatures at the time of off-loading from the vessel by the processor should be consistent with cooling curves that will prevent development of an unsafe level of histamine in the specific species, as established through a scientific study.
4.    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 HACCP plans for Fish Sauce lists monitoring procedures and frequencies at the “(b)(4)” critical control point that are not adequate to control scombrotoxin (histamine) formation. Specifically, the monitoring procedure for:
 
a.  Fish backbone temperature indicates that your firm will monitor fish backbone temperature by (b)(4). FDA recommends monitoring the internal temperature of the fish at time of delivery by using a temperature-indicating device (e.g., a thermometer) to determine internal product temperatures in a representative number of fish from throughout the shipment, at delivery for every scombrotoxin-forming fish lot received.
 
b.  Histamine level indicates that your firm will monitor the histamine level of the delivered lot of fish using a (b)(4) for every incoming lot of fresh chilled fish. FDA recommends monitoring the histamine content in the scombrotoxin-forming fish flesh by testing a minimum of 18 fish, collected representatively throughout each lot (or the entire lot when there are fewer than 18 fish in the lot) for every lot of scombrotoxin-forming fish received. When the fish are so small that the entire edible portion of the fish (from both sides of the fish) yields less than 250 grams, then collect each subsample from the entire edible portion of multiple fish until ≥ 250 grams is obtained. Additional fish should be examined if variability in fish-to-fish histamine content is expected to be high. Lots should consist of only one species of fish; for vessels delivering multiple species, testing should generally be done separately on each species.
 
5.    Because you chose to include a corrective action plan in their HACCP plan, the described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for fish sauce, at the following critical control points, to control the identified hazards, are not appropriate: 
 
a.  At the “(b)(4)” critical control point, to control the hazard of scombrotoxin formation, the corrective action plans do not ensure that the cause of the deviations are corrected. FDA recommends that firms discontinue use of the supplier until evidence is obtained that the identified harvesting and onboard practices have been improved. In addition, the corrective action plans for core temperature of the fish and adequacy of ice, do not ensure that no adulterated product enters commerce. FDA recommends that firms reject the lot.
 
b.  At the “(b)(4)” critical control point, to control the hazard of Staphylococcus aureus growth and toxin formation, the corrective action plan does not ensure that no adulterated product enters commerce. FDA recommends that firms only re-process the product (add salt) in the event reprocessing does not jeopardize the safety of the product. Otherwise firms should divert the product to a non-food use or destroy the product.
 
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 documentation reflecting the changes you made, 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 seafood HACCP regulation.  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. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
 
Additional Comments:
 
The critical limit, at the Final Salting of Fish critical control point, list a range of values rather than a maximum or minimum value for Fish to Salt Ratio. The critical limit should be the minimum value necessary to consistently achieve a water phase salt level of at least 20% or a water activity of 0.85 or below in the in-process product prior to fermentation. If the range is based on another critical factor (such as the size of the fish), then the HACCP plan should include critical limits for the other critical factor (e.g., size) and water phase salt level/water activity combinations.
 
The monitoring procedure at the Final Salting of Fish critical control point should indicate that the firm will weigh the fish and weigh the salt and then calculate the Fish to Salt Ratio. The monitoring record for this critical control point should include these weights and the results of the calculation.
 
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, and the Good Manufacturing Practice regulation (21 CFR 110).  You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Elizabeth Girard, 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: Elizabeth.Girard@fda.hhs.gov. Please reference CMS# 492219 on any submissions and within the subject line of any emails to us. You may also contact Elizabeth Girard 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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