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WARNING LETTER

Sinu Co., Ltd MARCS-CMS 585410 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Seafood/Seafood Product
Recipient:
Recipient Name
Dong Min Lee
Recipient Title
President
Sinu Co., Ltd

B-501, 1, Wonyang-ro, Seo-gu
Seo-gu
Busan
49277
South Korea

Issuing Office:
Center for Food Safety and Applied Nutrition

5001 Campus Drive
College Park, MD 20740-3835
United States

JUL 24,  2019                

WARNING LETTER

VIA EXPRESS DELIVERY

Dong Min Lee, President
Sinu Co., Ltd.
B-501, 1, Wonyang-ro, Seo-gu
Busan, Busan, 49277 Korea (the Republic of)


Reference# 585410

Dear Mr.  Lee:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Sinu Co., Ltd. located at B-501, 1, Wonyang-ro, Seo-gu, Busan, Busan, 49277 Korea (the Republic of) on April 8, 2019.  During that inspection, we found that you had serious 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 that inspection, the FDA investigator issued an FDA 483, lnspectional Observations, listing the observations made at your firm.  We acknowledge  receipt of your response sent via email on April 26, 2019.  Your response included a HACCP plan entitled "(Salted Shrimp) Acetes japonicus" dated April 8, 2019, completed monitoring records, product description, and flow charts.  However, our evaluation of your response revealed it 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 refrigerated salted shrimp (intended both to be cooked and as raw  ready-to-eat) 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.

Your significant deviations are as follows:

1.   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."  At the time of the inspection, your firm did not have a HACCP plan to control food safety hazards that are reasonably likely to occur for your shrimp.  Your firm provided a HACCP plan dated April 8, 2019 for "(Salted Shrimp) Acetes japonicus" with your April 26th response, however that plan lists critical limits that are not adequate to control pathogen growth.  Specifically,

a.   Your product specification identifies your finished product as salted shrimp in (b)(4) containers with (b)(4) tops. This would be considered a reduced oxygen packaged product, which requires controls for Clostridium botulinum (C. botulinum) growth and toxin formation in your finished product.  The flow chart you provided with your response indicates that the finished product is frozen.  When using freezing as a strategy to control C. botulinum, FDA recommends, the HACCP plan list a critical control point  that requires finished product labeling to state the product is to be kept frozen and thawed under refrigeration (e.g., "Important, keep frozen and thawed under refrigeration immediately before use") to ensure that the product is held frozen.

However, your finished product label includes handling instructions to "Keep Refrigerated." However, refrigeration alone is not adequate to control C. botulinum growth and toxin formation.

•     When freezing is selected as the control strategy for C. botulinum, then finished product labeling cannot list "Keep Refrigerated", thus your firm needs to amend your HACCP plan to ensure that all labels include the statement "Important, keep frozen and thawed under refrigeration immediately before use" and you need to amend your labels consistent with your HACCP plan.

•     When refrigeration is selected as the control strategy, a secondary barrier to control C. botulinum growth and toxin formation is necessary.  Your HACCP plan dated April 8th, lists a "(b)(4)" critical control point, with the listed critical limit of "(b)(4)" that is not adequate to control C. botulinum growth and toxin formation in conjunction with refrigeration.  When your control strategy for C. botulinum is both salting and finished product refrigeration, then the finished product water phase salt level needs to be 5% or more to control C. botulinum. Refrigeration at 40°F (4.4°C) or below will control other pathogens.  If this is your strategy, FDA recommends a critical limit that ensures the finished product water phase salt level is 5% or more to control C. botulinum and ensure refrigeration at 40°F (4.4°C} or below to control other pathogens.

b.   At the "(b)(4)" critical control point, the listed critical limit of "(b)(4)" is not adequate to control pathogen growth and toxin formation during unrefrigerated (b)(4).  Your firm receives the shrimp frozen and conducts a (b)(4) step that should be included in the "(b)(4)" critical control point. The flow chart provided with your response indicates that this critical control point applies to the steps of "(b)(4)", "Cleaning, and Salting."  The investigator noted during the inspection that your shrimp is thawed in your production room at (b)(4)°C before cleaning and salting.  Your critical limit should include the time and temperature exposure for thawing.  FDA recommends that your critical limit list ambient air temperatures below 50°F (10°C) throughout unrefrigerated processing that includes thawing, cleaning and salting.

2.    Because you chose to include a corrective action plan in your HACCP plan entitled ("Salted Shrimp) Acetes japonicus" dated April 8, 2019, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b).  However, your corrective action plan for your ("Salted Shrimp) Acetes japonicus" is not appropriate.  Specifically,

a.   At the "(b)(4)" and "(b)(4)" critical control points the listed corrective actions are not appropriate to control pathogen growth and toxin formation.  FDA recommends corrective actions address both the disposition of the affected products and address correcting the cause of the deviation.  For both critical control points, FDA recommends the affected product be chilled, held and evaluated for food safety based on cumulative time and temperature exposure in addition to modifying the procedures to address correcting the cause of the deviation.

b.   At the "(b)(4)" critical control point, the listed corrective action is not appropriate to control for undeclared allergens.  FDA recommends the critical limit list modifying the labeling procedure to correct the cause of the deviation, as appropriate, instead of the listed corrective action of "...pack in correct package."

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., records for the production of 5 production date codes of the 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 applicable laws and regulations.  Submission of the information in English will assist in our review.  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 believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.

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.

Upon further review of your FDA-483 response, we have the following comment.  According to your Process Flow Chart for Salted Shrimp (flow chart 2), your (b)(4) process may result  in a finished product salt level of at least (b)(4)% water phase salt , which would be considered a shelf-stable product (i.e., finished would not need refrigeration and the finished product labels would not need to include handling instructions to "Keep Refrigerated"). If your firm is also processing a shelf-stable salted shrimp product that achieves a finished product salt level of (b)(4)% water phase salt, you must have and implement a separate HACCP plan for this product as well.

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 117 Subpart B).  You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to Food and Drug Administration, Attention: Standra Purnell, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5001 Campus Drive, College Park, MD 20740 U.S.A.  If you have any questions regarding this letter, you may contact Ms. Purnell via email at standra.purnell@fda.hhs.gov.  Please reference CMS #585410 on any submissions and within the subject line of any emails to us.


Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition
 

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