- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameQuan Shijie
Recipient TitleGeneral Manager
- Donggang Hongxing Food Co., Ltd.
Liaoning Sheng, 118300
- Issuing Office:
- Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park, MD 20740
Dear Mr. Quan:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Donggang Hongxing Food Co., Ltd. located at Huangjiatun Group, Taoyuan Village, Xincheng Administrative, Donggang, Liaoning, China 118300 on May 22-23, 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 1 23). 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 6, 2019. Your response included a revised HACCP plan entitled "Frozen Boiled Short Necked Clam (Vacuum Packed)" dated June 1, 2019 and a spreadsheet outlining your corrections to the FDA 483. 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 boiled short necked clams (vacuum packed) 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." However, your firm' s revised HACCP plan entitled "Frozen Boiled Short Necked Clam (Vacuum Packed)," dated June 1, 2019, lists critical limits of:
a. "(b)(4)" critical control point that is not adequate to control pathogens because there is no corresponding critical limit for time. FDA recommends a minimum hold time of 2.0 minutes at a temperature of 70°C.
b. "(b)(4)" critical control point that is not adequate to control the recontamination of pathogenic bacteria during cooling after the cooking process. FDA recommends processors also ensure the cooling water contains residual chlorine or other approved water treatment chemical.
c. "(b)(4)" critical control point that is not adequate to control Clostridium botulinum because it does not list that handling instructions are included on each label to state that the product is to be thawed under refrigeration. FDA recommends each product label include the statement "Keep Frozen, Thaw under refrigeration immediately before use."
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 21CFR 123.6 (c)(4). However, your firm's revised HACCP plan entitled "Frozen Boiled Short Necked Clam (Vacuum Packed)" lists monitoring procedures and frequencies that are not adequate. Specifically, your revised HACCP plan lists at the "(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.
3. Because you choose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21CFR 123.7(b). Your firm's revised HACCP plan entitled "Frozen Boiled Short Necked Clam (Vacuum Packed)" lists corrective actions that are not adequate. Specifically,
a. At the "(b)(4)" critical control point, your revised HACCP plan lists "(b)(4)" FDA recommends that your corrective actions also list "Reject the lot."
b. At the "(b)(4)" critical control point, your revised plan lists "(b)(4)" FDA recommends that rather than conducting pathogen testing, your firm ensure the safety of the product by boiling the product again. In addition, FDA recommends correcting the cause of the deviation.
c. At the "(b)(4)" critical control point, your revised plan lists, "(b)(4)” FDA recommends your firm assess the safety of the product to ensure no adulterated products enter commerce. In addition, FDA recommends identifying and correcting the cause of the deviation.
d. At the "(b)(4)" critical control point, your revised plan lists "(b)(4)" FDA recommends, your firm segregate, and relabel any improperly labeled product. In addition, FDA recommends determining and correcting the cause of the deviation.
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 firstname.lastname@example.org . Please reference CMS #588707 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