Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
JAN 14, 2016
VIA EXPRESS DELIVERY
Mr. Wen-Pin Liu
Hsien-Pin Frozen Foods Co. Ltd.
21 Zyquiang Rd.
Ylan, 270, Taiwan
Reference No. CMS #486186
Dear Mr. Liu:
On September 24-25, 2015, a representative from the U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, Hsien-Pin Frozen Foods Co., Ltd. located at 21 Zyquiang Rd., Su-Ao Township, Ylan, 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.
We received your firm’s response to the FDA-483 sent via email on, October 30, 2015. Your response included a HACCP plan for “Frozen, Raw, Ocean Harvested Mahi mahi, Wahoo, steaks or fillets.” Our review of the documentation determined that the response 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 mahi mahi and wahoo 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 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 plan for “Frozen, Raw, Ocean Harvested, Mahi Mahi, Wahoo, steaks or fillets” lists critical limits at the following critical control points that are not adequate to control scombrotoxin (histamine) formation. Specifically:
a) At the “Receiving (Fresh and/or Frozen)” critical control point, your HACCP plan lists a critical limit of “(b)(4).” In addition to critical limits for histamine testing and sensory examination, your HACCP plan should include critical limits for:
- Internal temperature measurements of a representative number of the largest fish in the lot at the time of off-loading from the harvest vessel. FDA recommends that:
o For fish held iced or refrigerated (not frozen) onboard the vessel 24 or more hours after death:
The internal temperature should be 40°F (4.4°C) or below;
o For fish held iced or refrigerated (not frozen) onboard the vessel from 15 to less than 24 hours after death:
The internal temperature should be 50°F (10°C) or below;
o For fish held iced or refrigerated (not frozen) onboard the vessel from 12 to less than 15 hours after death:
The internal temperature should be 60°F (15.6°C) or below;
o For fish held iced or refrigerated (not frozen) onboard the vessel less than 12 hours after death:
The internal temperature should be sufficiently below water and air temperatures to indicate that appropriate chilling methods were implemented onboard the harvest vessel. Chilling of the fish should begin on the harvest vessel regardless of the time from death until off-loading from the vessel by the processor, unless the environmental conditions (e.g. air and water temperatures) are below 40°F (4.4°C) from the time of death until off-loading from the vessel by the processor;
o For fish held iced or refrigerated (not frozen) onboard the vessel:
Elapsed time from death and internal temperatures at the time of off-loading from the vessel by the processor should be consistent with cooling curves that will prevent development of an unsafe level of histamine in the specific species, as established through a scientific study.
- Transportation. FDA recommends that:
o For fish that are 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;
o For fish delivered under ice:
Fish are completely surrounded by ice at the time of delivery;
o For fish delivered under ice on an open-bed truck:
Fish are stored completely surrounded by ice;
The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;
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;
The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;
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;
Internal temperature of the fish at the time of delivery does not exceed 40°F (4.4°C).
b) At the “Defrost/icing/gutting/washing and icing” critical control point, your HACCP plan lists critical limits of, “(b)(4).” Although your critical limits appear to be adequate for scombrotoxin-forming fish that have been previously frozen, FDA recommends that, for raw scombrotoxin-forming fish that have not been previously frozen:
- The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 4 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C);
- The fish are not exposed to ambient temperatures of 40°F (4.4°C) for more than 8 hours, cumulatively, as long as no portion of that time is above 70°F (21.1°C).
2) 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, Raw, Ocean Harvested Mahi mahi, Wahoo, steaks or fillets” at the following critical control points to control scombrotoxin (histamine) formation are not appropriate:
a) At the “Receiving (Fresh and/or Frozen)” critical control point, your corrective action plan indicates that you will “(b)(4)”. FDA recommends that:
- When the histamine level exceeds the critical limit (i.e., when any of the composited test units (consisting of 2 fish) in the lot is 25 ppm or more histamine), reject the lot;
- When the sensory examination exceeds the critical limit (i.e., if decomposition 2.5% or greater), you chill and hold the affected lot until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the lot, or the entire lot for lots smaller than 60 fish. If any fish is found with histamine greater than or equal to 50 ppm, then reject the entire lot.
- Discontinue use of the supplier until evidence is obtained that the identified harvesting and onboard practices have been improved.
b) At the “Defrost/icing/gutting/washing and icing” critical control point, your corrective action plan lists “(b)(4)” among other possible corrective actions. FDA recommends that your corrective action plan includes the steps to be taken with regard to sampling, evaluating, and responding to the result of histamine testing. In addition, you 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 if histamine greater than or equal to 50 ppm is found in any fish, destroy the lot or divert it to a non-food use.
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: email@example.com. Please reference #CMS 486186 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.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition