Inspections, Compliance, Enforcement, and Criminal Investigations

Jin Tzer Marine Products Co. Ltd. 7/28/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

 

JUL 28, 2016
WARNING LETTER
 
VIA EXPRESS DELIVERY
 
Kuan-Liang (Monica) Huang, Plant Manager
J in Tzer Marine Products Co. Ltd.
No. 26, Lixing 2nd road
Wujie Township
Yilan County 268 Taiwan (R.O.C.)
 
Reference # 500281
 
Dear Ms. Huang:
 
In response to a request from the U.S. Food and Drug Administration (FDA) for HACCP related documentation associated with the processing of your fish and fishery products, your firm provided a process flow chart for scombrotoxin (histamine) forming fish, a process description hazard analyses, HACCP plans for various forms of your scombroid (histamine) forming fish and completed monitoring records for your scombroid (histamine) forming fish sent via email on April 26, 2016. Our evaluation of those HACCP plans and supporting documentation revealed serious deviations from the requirements of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations Part 123 (21 CFR  123), as further explained 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 scombroid (histamine) forming fish 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. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.htm.
 
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 HACCP plans entitled "Frozen Raw Material HACCP plan (dolphin fish pieces, fish bar)" and "Frozen fish pieces, fish bar" each list critical limits at the "Processing" critical control points that product is not out of refrigeration for more than (b)(4) that are not adequate to control scombrotoxin (histamine) formation because there are no corresponding critical limits listed for the ambient temperatures associated with each of the processing times. FDA recommends that your firm include corresponding temperature exposures (i.e., unrefrigerated temperature) for each time period. For example, FDA recommends that fish are not exposed to ambient temperature 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 the fish are not exposed to ambient temperature 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).
 
You should monitor the length of time that the scombrotoxin (histamine) forming fish are exposed to unrefrigerated conditions from when the first fish in a marked batch is exposed to an ambient temperature above 40°F (4.4 °C) until the last fish in the batch is placed in the freezer.
 
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 HACCP plan for "frozen raw material HACCP plan (Dolphin fish pieces, fish bar)" lists monitoring procedures at the 'Thawing" critical control point that are not adequate to control scombrotoxin (histamine) formation because they do not ensure that your firm will consistently meet the critical limits listed at this same critical control point. Specifically, your monitoring procedures indicate you monitor "(b)(4)." However, these monitoring procedures are not consistent with your critical limits that are listed as "(b)(4)." In order to meet your critical limits, your firm will need to continuously monitor the thawing water temperatures to ensure that the fish are not exposed to temperatures above 40°F (4.4°C) at any time during the entire duration of the thawing cycle.
 
3. 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 HACCP plan entitled '·Frozen fish pieces, fish bar'· does not list critical control points for thawing or in-process storage for controlling the food safety hazard of scombrotoxin (histamine) formation.
 
4. Because you chose to include a corrective action plan in your HACCP plan your described corrective action must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective actions included in your HACCP plan entitled '"Frozen Raw Material (dolphin Fish Pieces, fish bar)” at the "Thawing” critical control point is not adequate to control the hazard of scombrotoxin (histamine) formation. Specifically, your listed corrective actions of adding ice to the water after the critical limits have been exceeded does not ensure that adulterated product is not shipped into commerce and does not correct the cause of the critical limit deviation. In addition, your firm should modify the process as needed to reduce the time and temperature exposure.
 
For more information on controlling the scombrotoxin hazard, FDA recommends you review Chapter 7 of the Fish and Fishery Products Hazards and Control Guidance Fourth Edition. This Guidance can be found at the following web address:
 
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 or plans, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for each critical control point that cover 5 full production date codes of products) to demonstrate implementation of the plan, information related test methodologies that describe testing methods 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 seafood HACCP regulation. 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 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.htmI.
 
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 standra.purnell@fda.hhs.gov. Please reference #500281 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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