Recipient NameWen-An Chen
- Taiwan Sing Rong Food Co., LTD
No. 16 Chuan Chiang Lane
Chi Nan 1st Road, Chi Shan District
Kaohsiung City, 842
- Issuing Office:
- Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park, MD 20740
APRIL 9, 2018
VIA EXPRESS DELIVERY
Wen-An Chen, General Manager
Taiwan Sing Rong Food Co. Ltd.
No. 16 Chuan Chiang Lane, Chi Nan 1st Road, Chi Shan District
Kaohsiung City, 842 Taiwan
Dear Mr. Wen-An Chen:
On December 18-21, 2017, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility Taiwan Sing Rong Food Co., Ltd. located at No. 16, Chuan Chiang Lane, Chi Nan 1st Rd., Chi Shan District, Kaohsiung City, Taiwan. That inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). That inspection resulted in FDA's issuance of an FDA 483, lnspectional Observations that lists the serious deviations found at your firm.
We acknowledge receipt of your response sent via email on January 8, 2018. Your response included revised pages of your HACCP plan, completed monitoring records, and photographs. We have evaluated the documentation and found that you have continuing serious deviations of the seafood HACCP regulation, as further explained in this letter.
In accordance with 21CFR123.6(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 Hot Pot (fish) dumpling product is adulterated, in that it has 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 21CFR123.6 (c}(3). A critical limit is defined in 21CFR123.3 (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, the pages of your firm's HACCP plan for "Hot Pot (fish) dumpling provided with your January 8,2018 response lists critical limits that are not adequate to control your identified hazard of "pathogenic bacteria growth and toxin formation as a result of time and temperature abuse". Specifically, at the "(b)(4)" critical control point your plan lists "(b)(4)". However, your frozen raw squid is described as (b)(4). This packaging type creates a potential for toxin formation (i.e., Clostridium botulinum growth and toxin formation) because the oxygen in the bags could be depleted during thawing, creating anaerobic conditions. Consequently, the appropriate holding temperature for the raw squid is 3.3°C (38°F). FDA recommends your firm list a critical limit of 3.3°C (38°F) or less with continuous monitoring and recording of the ambient temperature during the entire thawing cycle to prevent the toxin formation. Alternatively, your firm has the option of eliminating the hazard of Clostridium botulinum toxin formation by opening the packages to allow the oxygen transfer during the thawing process.
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21CFR123.6(c)(4). However, the pages of your firm's HACCP plan for "Hot Pot (fish) dumpling" provided with your January 8, 2018 response list monitoring procedures/frequencies at the "(b)(4)" and "(b)(4)" critical control points that are not adequate to control your identified hazard of "pathogenic bacteria growth and toxin formation as a result of time and temperature abuse". Specifically, the pages of your firm's HACCP plan list that "(b)(4)" is performed, however there is no frequency provided for when or how often these checks are performed. Moreover, intermittent manual temperature checks are not adequate for steps that expose product to potential time and temperature abuse. FDA recommends that your firm have a continuous time/temperature recording device.
3. Predetermined corrective action plans included in a firm's HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21CFR123.7(b). However, your corrective action plan for Hot Pot (fish) is not adequate at the process temperature control critical control point ((b)(4)) to ensure that no adulterated product enters commerce and that the cause of deviation is corrected. Specifically, your plan states "(b)(4)" and "(b)(4)." Testing for pathogens alone is not an effective means of determining the safety of the entire lot of product when a process deviation has occurred. To determine proper disposition of the product, the corrective action should include assessment of the time and temperature exposure of the product. Alternatively, the affected product could be destroyed. Additionally, the equipment should be repaired, replaced, or recalib rated to ensure the cause of the deviation has been corrected.
We have the following comment and requests for additional information:
1. Please ensure that the packages of your frozen products, including your Hot Pot (fish), Shrimp Rolls, Cuttlefish Rolls and Egg Dumpling (i.e., with fish paste) have handling instructions to consumers to "Thaw Under Refrigeration; Use Immediately Before Use", or similar instructional language to ensure that the products are properly thawed prior to consumption.
2. Please provide the entire HACCP plan for your Hot Pot (fish). Your January 8, 2018 response includes only 2 pages from the plan.
3. Please provide the HACCP plans for your Shrimp Rolls, Cuttlefish Rolls and Egg Dumpling (i.e., with fish paste).
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 remain ing 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 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. Reinspection- 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 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 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 email@example.com. Please reference CMS #552394 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