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  5. Shang Jiuan Co., LTD - 588770 - 08/15/2019
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WARNING LETTER

Shang Jiuan Co., LTD MARCS-CMS 588770 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Shang Jiuan Co., LTD

No. 1 Dail Road, Sec. 2.
Donggang Township, Pingtung County 92849
Taiwan

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

AUG 15, 2019

WARNING LETTER


Reference# 588770

Dear Ms. Su:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Shang Jiuan Co., Ltd. located at No. 1 Dail Road, Sec. 2 Donggang Township, Pingtung County, 92849, Taiwan on May 20-21, 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 June 26, 2019. Your response included a revised HACCP plan entitled "Frozen fish meat (Flake, block strip, diced, whole round fish and other shapes" dated May 28, 2019, completed process quality monitoring records, and written corrective action plan. 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 frozen tuna (ready-to-eat and ready-to-cook) is adulterated, in that it has been prepared, packed, or held under conditions whereby it 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 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 revised HACCP plan entitled "Frozen fish meat (Flake, block strip, diced, whole round fish and other shapes," which includes both ready-to-eat and ready-to-cook tuna products, does not list critical control points for controlling the food safety hazards of scombrotoxin (histamine) formation and pathogen growth and toxin formation (for your products intended as raw, ready-to-eat). Specifically, your firm's revised HACCP plan entitled "Frozen fish meat (Flake, block strip, diced, whole round fish and other shapes" does not list a critical control point (CCP) of;

a. Refrigerated thawing of your frozen fish. During the inspection our investigator noted that your firm holds the tuna for up to (b)(4) hours during thawing. Once you have included this as a CCP FDA recommends that:

• The product is held at a cooler temperature of 40°F (4.4°() or below. Note that the allowance for routine refrigeration defrost cycles a may be necessary;
OR
• The product is completely and continuously surrounded by ice throughout the storage time

b. Unrefrigerated processing to control scombrotoxin (histamine) formation and pathogen growth and toxin formation as a result of time and temperature abuse. During the inspection our investigator noted that your firm exposes the tuna to unrefrigerated conditions during processing/handling for XXXX amount of time. Once you have included this as a CCP, FDA recommends that:

• To control scombrotoxin (histamine) formation during processing of scombrotoxin-forming fish or fishery products that have been previously frozen, FDA recommends that:

o The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 12 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C);
OR
o The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 24 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C).

• To control pathogen growth and toxin formation as a result of time and temperature abuse for your raw, ready-to-eat products, FDA recommends that:

o If at any time the product is held at internal temperatures above 70°F (21.1 °C), exposure time (i.e., time at internal temperatures above S0°F (10°C) but below 135°F (57.2°C)) should be limited to 2 hours (3 hours if Staphylococcus aureus is the only pathogen of concern),
OR
o Alternatively, exposure time (i.e., time of internal temperatures above 50°F (10°C) but below 135°F (57.2°C)) should be limited to 4 hours, as long as no more than 2 of those hours are between 70°F (21.1 °C) and 135°F (57.2°C);
OR
o If at any time the product is held at internal temperatures above 50°F (10°C) but ever above 70°F (21.1°C), exposure time at internal temperatures above 50°F (10°C) should be limited to 5 ours (12 hours if Staph aureus is the only pathogen of concern);
OR
o The product is held at internal temperatures below 50°F (10°C) throughout processing,
OR
o Alternatively, the product is held at ambient temperatures below 50°F (l0°C) throughout processing.

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." Your firm's revised HACCP plan entitled "Frozen fish meat (Flake, block, strip, diced, whole round fish and other shapes)", does not list a critical limit at the "(b)(4)" critical control point that is adequate to control Clostridium botulinum growth and toxin formation, which is reasonably likely to occur during refrigerated storage of the product in sealed bags after treatment. Your firm lists "(b)(4)". However, FDA does not recommend listing critical limits during refrigerated storage steps that are associated with product temperatures. FDA recommends that firms include critical limits associated with ambient storage temperatures such as:

• The product is held at a cooler temperature of 38°F (3.3°C) or below with continuous monitoring and recording of the ambient temperature of the cooler.
OR
• The product is completely and continuously surrounded by ice throughout the storage time.

3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c}(4). However, your firm's revised HACCP plan entitled "Frozen fish meat (Flake, block, strip, diced, whole round fish and other shapes)" lists a monitoring frequency that is not adequate to control scombrotoxin (histamine) formation. Specifically, at the "(b)(4)" critical control point your revised plan lists a monitoring frequency of "(b)(4)" for histamine testing. FDA recommends testing of every lot of tuna at receiving.

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.

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# 588770 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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