Inspections, Compliance, Enforcement, and Criminal Investigations

Hochico Marine Processing Corp. 2/4/16

  

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

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

FEB 4, 2016

WARNING LETTER
 
 
VIA EXPRESS DELIVERY
 
Mr. Cheng Lung Lo
President
Hochico Marine Processing Corp.
29, Dexing 1st Rd., Su-Ao Township
Ylan 270, Taiwan
 
Reference No: 487486
 
Dear Mr. Lo,
 
On September 22-23, 2015, a representative from the U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, Hochico Marine Processing Corporation located at 29, Dexig 1st Rd., Su-Ao Township, Ylan 270, Taiwan. 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 the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm. To date, we have not received a written reply to the FDA-483.
 
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 mahi-mahi products 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/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm.
 
Your significant deviations are as follows:
 
1.    You must conduct, or have conducted for you a hazard analysis for each kind of fish and fishery product you produce 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 food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your HACCP plan for “Frozen Mahi-Mahi Fillet and Portion” does not list the food safety hazard of C. botulinum toxin formation. FDA recommends that you establish control measures to ensure that all finished product labels contain a “keep frozen” statement (e.g., “Important, keep frozen until used, thaw under refrigeration immediately before use”).
 
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." However, your HACCP plan for “Frozen Mahi-Mahi Fillet and Portion” lists critical limits at the following critical control points that are not adequate to control scombrotoxin (histamine) formation:
 
a.    At the “Check (Frozen Fish)” and “Check (Chilled Fish)” critical control points, your HACCP plan lists a critical limit for sensory examination of “(b)(4).” FDA recommends that sensory examination of a representative sample of scombrotoxin-forming fish shows decomposition (persistent and readily perceptible) in less than 2.5% of the fish in the sample.
 
b.    At the “Check (Chilled Fish)” critical control point, your HACCP plan lists a critical limit for internal temperature of the product of “Product temperature should be controlled (b)(4).” 
  • To control histamine formation that may occur during transit from the harvest vessel to the processing plant, FDA recommends:
o   For fish delivered refrigerated (not frozen): All lots received are accompanied by transportation records that show that the fish were held at or below an ambient or internal temperature of 40°F (4.4°C) throughout transit. Note that allowance for routine refrigeration defrost cycles may be necessary;
 
OR
 
o   For fish delivered under ice: Fish are completely surrounded by ice at the time of delivery;
 
OR
 
o   For fish delivered under ice on an open-bed truck:
 
Fish are stored completely surrounded by ice;
 
AND
 
The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;
OR
o   For fish delivered under chemical cooling media such as gel packs:
 
There is an adequate quantity of cooling media that remain frozen to have maintained product at an internal temperature of 40°F (4.4°C) or below throughout transit;
 
AND
 
The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;
OR
 
o   For fish delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less (optional control strategy):
 
Time of transit does not exceed 4 hours;
 
AND
 
Internal temperature of the fish at the time of delivery does not exceed 40°F (4.4°C).
 
c.    At the “Thawing” critical control point, your HACCP plan lists a critical limit of “(b)(4).” Generally, FDA considers thawing to be an unrefrigerated processing step unless it is conducted in a cooler. FDA recommends that:
  • During processing (e.g., thawing, butchering, cleaning, brining, mixing, fermenting, stuffing, packing, labeling, and staging) of scombrotoxin-forming fish or fishery products that have been previously frozen:
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).
 
Alternatively, you may wish to consider this step as refrigerated processing because of the use of ice and water. For refrigerated processing of raw material, in-process product, or finished product, FDA recommends that the product is held at an ambient temperature of 40°F (4.4°C) or below.
 
Please note: In both of these cases, the ambient temperature would be the temperature of the ice and water slurry at warmest spot in the thawing sink. 
 
d.    At the “Preservation by Cold Water” critical control point, your HACCP plan lists a critical limit of “(b)(4).” Generally, FDA would consider storage in ice and water (i.e., a slurry of ice and water) to be a refrigerated storage step.
  • For refrigerated (not frozen) storage of raw material, in-process product, or finished product, FDA recommends that the product is held at an ambient temperature of 40°F (4.4°C) or below.
Alternatively, you may wish to consider this step to be a part of your unrefrigerated processing. During processing (e.g., thawing, butchering, cleaning, brining, mixing, fermenting, stuffing, packing, labeling, and staging) of scombrotoxin-forming fish or fishery products that have been previously frozen, FDA recommends that:
  • 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
  • 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).
Please note: In both of these cases, the ambient temperature would be the temperature of the ice and water slurry at warmest spot in the thawing sink.
 
3.    Because you chose 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). However, your corrective action plans for Frozen Mahi-Mahi Fillet and Portions, at the “Check (Frozen Fish)”, “Check (Chilled Fish)”, “Thawing”, “Preservation by Cold Water”, and “Filleting to Tray Arrangement” critical control points, to control the hazards of scombrotoxin formation, are not appropriate. Your corrective actions plans do not ensure the cause of the deviation is corrected. In addition, your corrective action plans at the “Thawing”, “Preservation by Cold Water”, and “Filleting to Tray Arrangement” critical control points do not ensure that no adulterated product enters commerce. FDA recommends that:
 
a.    At the “Check (Frozen Fish)” and “Check (Chilled Fish)” critical control points, the corrective actions also include discontinue use of the supplier until evidence is obtained that the identified harvesting and onboard practices have been improved.
 
b.    At the “Thawing” and “Filleting to Tray Arrangement” critical control points, in addition to specifying that you will “(b)(4)”, your corrective action plan should specify:
  • Chill and hold the affected product until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the affected lot,
AND
  • Modify the process as needed to reduce the time and temperature exposure
c.    At the “Preservation by Cold Water” critical control point, in addition to specifying that you will “(b)(4)”,  your corrective action plan should specify:
  • Chill and hold the affected product until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the affected lot,
AND
  • Modify the process as needed to reduce the time and temperature exposure.    
Additional comment:
 
The critical limits and monitoring procedures listed in your HACCP plan for “Frozen Mahi-Mahi Fillet and Portion” at the “Filleting to Tray Arrangement” critical control point should indicate that the critical limits start, and the monitoring begins, when the first fish from the batch is removed from refrigerated storage until the last trimmed loin from the batch is placed in the freezer. In addition, the cumulative time of exposure includes all of the time that fish are exposed to ambient temperatures above 40°F (4.4°C), including time of exposure at previous processing steps. As noted above, the ambient temperature at the “Thawing” and Preservation by Cold Water” critical control points would be the temperature of the ice and water slurry at the warmest spot in the thawing sink.
 
You should respond in writing within 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 HACCP plan, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of 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 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.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 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 the U.S. Food and Drug Administration, Attention: Aleta T. Flores, Compliance Officer, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: aleta.flores@fda.hhs.gov. Please reference #CMS 487486 on any submissions and within the subject line of any emails to us. You may also contact Aleta T. Flores via email if you have any questions about this letter. 
 
Sincerely,
/S/ 
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition

Page Last Updated: 02/12/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.