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  5. Dandong Shenghai Foodstuff Co. Ltd. - 588709 - 08/15/2019
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Dandong Shenghai Foodstuff Co. Ltd. MARCS-CMS 588709 —

Delivery Method:
Via Express Delivery
Food & Beverages

Recipient Name
Jin Tao
Recipient Title
Vice General Manager
Dandong Shenghai Foodstuff Co. Ltd.

Youhao Road East, Qiaonan Economic Development Zone
Liaoning Sheng, 118300

Issuing Office:
Center for Food Safety and Applied Nutrition

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

AUG 15, 2019

Reference# 588709

Dear Mr. Jin:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Dandong Shenghai Foodstuff Co., Ltd. located at Youhao Road East, Qiaonan Economic Development Zone, Donggang, Liaoning, China 118300 on May 16-17, 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 4, 2019. Your response included a HACCP plan entitled "Frozen short neck clam" dated May 23, 2019 and a document titled "Rectification report of nonconformity items." 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, cooked short neck clams 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 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 short neck clams," dated May 23, 2019, does not list a container integrity critical control point to control the recontamination of pathogenic bacteria during cooling after the cooking process. FDA recommends processors ensure the cooling water contains residual chlorine or other approved water treatment chemical.

2. 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 short neck clams" lists monitoring procedures and frequencies that are not adequate. Specifically, your revised HACCP plan lists at the:

a. "(b)(4)" critical control point, a monitoring frequency of "(b)(4)" that is not appropriate to control natural toxins. FDA recommends you visually check incoming tags of every container.
b. "(b)(4)" critical control point, a monitoring procedure and frequency that is not adequate to control pathogenic bacteria. Your revised plan indicates you will:
• Monitor the cooking tunnel water temperature using a "(b)(4)". FDA recommends monitoring batch cooking by using a continuous temperature-recording device installed where it measures the coldest temperature of the cooking equipment.
• Visually check the belt frequency (b)(4). FDA recommends your firm's monitoring procedures also list monitoring the belt speed, in addition to cooking water temperature. This may be measured with a stopwatch or tachometer to monitor the speed of the belt drive wheel; or a stopwatch to monitor the time
necessary for a test unit or belt marking to past through the equipment at least once per day and whenever any changes in belt speed are made.

3. Because you choose 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). Your firm's corrective action at the "(b)(4)" critical control point is not an appropriate action to take when a critical limit is not met at receiving. Specifically, when supply certificate information is not on the label, the revised HACCP plan lists a corrective action of "(b)(4)." In addition, FDA recommends that your corrective actions also include discontinuing use of that supplier until evidence is obtained that the supplier will comply with the certification controls.

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 #588709 on any submissions and within the subject line of any emails to us.



William A. Correll
Office of Compliance
Center for Food Safety
   and Applied Nutrition

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