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  5. Shin Ho Sing Ocean Enterprise Co., Ltd. - 506326 - 09/30/2016
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WARNING LETTER

Shin Ho Sing Ocean Enterprise Co., Ltd. MARCS-CMS 506326 —


Recipient:
Shin Ho Sing Ocean Enterprise Co., Ltd.


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
SEPT 30, 2016 
 
VIA EXPRESS DELIVERY
 
 
Mr. Martin K. L. Lin, Assistant General Manager
Shin Ho Sing Ocean Enterprises Co., Ltd.
No. 31 Fishing Harbor South 1st Road
Chien Chen District
Kaohsiung, 806
Taiwan
 
Reference No. # 506326
 
Dear Mr. Lin:
 
On June 13, 2016, a representative of the United States Food and Drug Administration (FDA) collected a copy of your firm’s HACCP plan for frozen cooked saury plan (copy enclosed) during an inspection of Hadson (Toko) Trading Co., Inc., an importer of fish and fishery products located in Maspeth, New York. That importer was found to be importing frozen cooked saury from your processing facility. We have conducted an assessment of that HACCP plan to determine your firm’s compliance with the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Titled 21, Code of Federal Regulations, Part 123 (21 CFR 123). Upon further review of that HACCP plan we find that your firm is in violation of the Federal Food, Drug, and Cosmetic Act (the Act). 
 
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 frozen cooked saury 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 FDA’s 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.  
The 4th Edition of the Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm
 
We found the following significant deviations:
 
1.    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 frozen cooked saury does not list critical control points for unrefrigerated processing to control the food safety hazard of scombrotoxin (histamine) formation.  According to your standard operating procedure document, your firm conducts multiple processing steps, which include (b)(4) and (b)(4) prior to the “Cooking” critical control point, where the fish are potentially exposed to temperatures between 4.4°C and 21.1°C (40°F -70°F). When processing fish under unrefrigerated/uncontrolled temperatures, FDA recommends monitoring time in order to limit the cumulative exposure time to 12 hours total for all unrefrigerated processing steps when ambient temperatures do not exceed 21.1°C (70 °F) to control scombrotoxin (histamine) formation. When exposure temperatures exceed 21.1°C (70°F) the cumulative time should be limited to 3 hours.
 
2.    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 frozen cooked saury lists a critical limit “cooking temp min (b)(4) for total time min (b)(4).” at the “Cooking” critical control point that is not adequate as the sole critical limit to control the hazard of pathogen survival through the cook, as identified in your HACCP plan.  FDA recommends the critical limit include all critical factors (e.g., initial temperature of the product, pouch thickness/size, product size, product formulation, etc.) established by a scientific study. Moreover, your scientific study needs to ensure that these critical factors achieve a minimum 6 log reduction of Listeria monocytogenes, which is the target organism for your product.
 
3.    Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b).   Corrective actions must address both the disposition of the affected products and address the cause of the deviation. However, your corrective action plan for frozen cooked saury lists inadequate corrective actions at the following critical control points:
  • At the critical control point of “Receiving primary materials (saury)” the listed corrective actions are not adequate in association with a histamine testing strategy. The corrective actions for histamine of 50ppm or greater should not list additional testing of 60 fish for histamine. FDA does not recommend additional testing of fish once the critical limit has been exceeded. Consequently, your corrective action should include rejecting the entire lot of fish.
  • At the critical control point of “Receiving primary materials (saury)” the listed corrective actions are not adequate for the sensory examination for decomposition. In addition to conducting sensory examination on all of the fish, FDA recommends holding and chilling the lot until an additional 60 fish are histamine tested to ensure less than 50 ppm in all 60 fish. This is in addition to conducting sensory evaluation of all fish in lot, destroying all decomposed fish and discontinuing use of the supplier.
  • At the critical control point of “Cooking” the listed corrective actions are not adequate. FDA recommends the listed corrective actions also address the disposition of the affected product, such as recooking the product, or diverting the product to a non-food use, or destroying the product.
You should respond in writing within fifteen (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 frozen cooked saury 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:
  • According to your HACCP plan for frozen cooked saury, your firm packages the finished product in a “(b)(4)-bag,” which may be an oxygen impermeable package, and distributes the product frozen. If the final package is oxygen impermeable, FDA recommends the product be frozen immediately after cooking in packaging with proper labeling. As such, the HACCP plan should list a critical control point for packing. The critical limit should list each individual finished product label must contain the statement “Important, Keep frozen until used, thaw under refrigeration immediately before use.” 
  • In addition to identifying the food safety hazard of scombrotoxin (histamine) formation at an unrefrigerated processing critical control point, your firm may also need to identify the hazard of pathogen growth and toxin formation, specifically Staphylococcus aureus, if your firm significantly handles the saury after the roasting step.
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: Brandon Bridgman, Compliance Officer, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5001 Campus Drive, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: brandon.bridgman@fda.hhs.gov. Please reference CMS# 506326 on any submissions and within the subject line of any emails to us. You may also contact Brandon Bridgman via email if you have any questions about this letter. 
 
 
 
Sincerely,
/S/ 
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
     and Applied Nutrition