Yangpo Foods Co.,Ltd. 9/5/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740 |
September 5, 2012
VIA EXPRESS DELIVERY
Mr. Lee Won-Woo
Yangpo Foods Co., Ltd.
Reference No. 335122
Dear Mr. Won-Woo:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood manufacturing facility, Yangpo Foods Co., Ltd., located at 247 Yangpo-ri, Janggi-Myun, Pohang, Korea on April 26 – 27, 2012. During that inspection, we found that you had deviations from 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 acknowledge receipt of your response dated May 11, 2012, where you provided a written response to the 483 observations. Your response included revised HACCP plans for canned mackerel in brine and canned mackerel-pike in brine. However, our evaluation of the documentation found that the response was not adequate and we noted additional deviations as further described in this letter.
In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of 21 CFR part 123, renders the 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 firm’s canned mackerel and canned mackerel-pike in brine are adulterated in that the products have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulation through links in FDA’s home page at www.fda.gov
We note the following serious deviations from the requirements of the Seafood HACCP regulation:
1. 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(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 plans do not list appropriate critical control points.
a. Your revised HACCP plans for canned mackerel and canned mackerel-pike in brine fail to list two distinct critical control points for receiving fresh fish to control the hazard of histamine formation that distinguish between your activities as (1) a primary processor receiving fresh mackerel directly from the harvest vessels; and (2) a secondary processor receiving the mackerel after transit from the point of off-loading from the harvest vessel.
i. Receiving as a primary processor. Your firm acts as the primary processor responsible for ensuring that adequate handling of the fish occurred onboard the harvest vessels. Your plan lists that you are conducting histamine testing. However, your firm should also conduct sensory evaluation and monitor internal temperatures of the fish at the wharf to ensure that the fish were properly handled onboard the vessels. Additionally, because there is the potential for commingling fish from several boats between off-loading from vessels and preparing the fish for transport in the vehicles, your firm should ensure that sampling reflects the conditions the fish were subjected to on each individual vessel.
ii. Receiving as a secondary processor. Our investigator observed that you received fresh mackerel at your facility that was transported from a wharf in Pusan. Consequently, your firm needs a separate receiving control to assess the conditions the fish were subjected to during transit to your facility.
b. Your HACCP plans for canned mackerel in brine and canned mackerel-pike in brine fail to list critical control points related to time and temperature exposures during processing to control histamine formation. The fish undergo multiple processing steps, including thawing, cutting, culling, brining, washing, can filling, weighing, exhausting, adding packing medium, can seaming, and staging for retorting.
i. For mackerel and mackerel-pike you receive frozen, your cumulative time of exposure to temperatures above (b)(4) from the start of thawing (when temperatures during thawing are not maintained (b)(4) to retort should be (b)(4) when the product is exposed to ambient temperatures (b)(4) at any point in time, (b)(4) when the product is exposed to ambient temperatures that never (b)(4). Our investigator observed that your firm may be exceeding these time and temperature recommendations. For example, our investigator noted that your firm conducts two distinct thawing steps, the first when the fish are (b)(4) and the second when the fish are held in a “thawing tank” where water is (b)(4). Your plan includes one “Thawing” critical control point that appears to reflect the thawing tank step. However, your plan does not include the overnight thawing that occurs prior to the thawing tank step.
After thawing, the fish are then are exposed to temperatures (b)(4) during rinsing, slicing, and packing. Consequently, your firm needs to assess all time periods when the fish are exposed to unrefrigerated conditions as part of the overall cumulative exposure times conducive to histamine development.
ii. For mackerel and mackerel-pike you receive fresh, your cumulative the time of exposure to temperatures (b)(4) from the start of processing to retort should (b)(4) when the product is exposed to ambient temperatures (b)(4) at any point in time, or (b)(4) when the product is exposed to ambient temperatures that never (b)(4).
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 “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 for canned mackerel in brine and canned mackerel-pike in brine do not list critical limits that are adequate to control the food safety hazard of histamine formation at the receiving and thawing critical control points.
a. Your HACCP plan for canned mackerel in brine fails to list a critical limit for sensory evaluation for decomposition and internal temperature at your “Raw Material Receiving” Critical Control Point to control histamine formation. As discussed above, your firm lists testing of histamine levels as the sole strategy at receipt of the fish from boats. However, as a primary processor your firm should also monitor internal temperature and conduct sensory evaluation of fresh fish at the time of off-loading from the vessel to ensure the fish were adequately handled aboard the harvest vessels. FDA recommends testing a representative sample of a minimum of 118 fish for every lot with no more than 2.5% of the sample showing signs of decomposition.
We note that your “Criteria sheet of canned mackerel Quality Control” appears to reflect the critical control points; however, these controls are not included in your HACCP plan. Your HACCP plan should be modified to include all critical control points in your process.
b. Your HACCP plan for canned mackerel-pike fails to list a critical limit for decomposition at your “Raw Material Receiving” critical control point. In addition to testing of histamine levels of the mackerel-pike at initial receipt of raw material from boats for controlling scombrotoxin, FDA also recommends conducting sensory evaluations of frozen fish. FDA recommends that you test a minimum of 118 fish for every lot.
3. 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 plans for canned mackerel and canned mackerel-pike do not list adequate monitoring procedures.
a. At the Receiving critical control point, your canned mackerel-pike plan lists that you are conducting histamine testing every lot, but does not list the number of fish to be analyzed. FDA recommends performing histamine analysis on a minimum of 18 fish collected representatively from each harvest vessel lot at receipt.
b. At the Receiving critical control point, your canned mackerel plan lists monitoring procedures of (b)(4) which do not adequately identify your testing method for histamine. Your HACCP plan should be more specific about the test method your firm is using.
c. At the Thawing critical control point, your canned mackerel-pike plan lists that you will monitor the thawing temperatures (b)(4) however, the process is listed as occurring for (b)(4). Your HACCP plan should ensure the temperatures are monitored for each batch.
4. 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, the corrective actions listed in your HACCP plans for canned mackerel and canned mackerel-pike are not appropriate.
a. For canned mackerel and mackerel-pike, your corrective action plan at your “Raw Material Receiving” critical control point does not include a corrective action to regain control over your operation.
b. For your mackerel-pike, the corrective action at your thawing critical control point does not include a corrective action to regain control over your operation.
5. You must conduct a hazard analysis for each kind of fish and fishery product that 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 firm’s HACCP plans for canned mackerel in brine and canned mackerel-pike in brine do not list the food safety hazard of undeclared allergens.
Fish is identified as one of the eight major allergens. Every finished product must be properly labeled with the appropriate species name of the fish to inform sensitive individuals. Your HACCP plan should include controls to assure this.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation of your corrections, such as a copy of any revised HACCP plans; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan; verification records; and any other useful information that would assist us in evaluating your corrections. 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. Providing your documentation in English will assist in our review.
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 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. This alert can be found on FDA’s web site at: http://www.fda.gov/ora/fiars/ora_import_ia16120.html
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 one or more inspections 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 the letter to your U.S. Agent.
Please send your reply to the Food and Drug Administration, Attention: Carol D’lima, CFSAN Office of Compliance, Division of Enforcement, Food Adulteration
Assessment Branch HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Carol.Dlima@fda.hhs.gov
. Please reference FEI #3002808658 on any submissions and within the subject line of any emails to us. You may also contact Carol D’lima at (240) 402-2033 or by email if you have any questions about this letter.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety and Applied Nutrition