Inspections, Compliance, Enforcement, and Criminal Investigations
Kuang Pei San Food Products Public Col, PLC. 8/16/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD 20740
August 16, 2012
VIA EXPRESS DELIVERY
Mr. Salil Tohtubtiang
Chief Executive Officer
Kuang Pei San Food Products Public Col, PLC.
88/9 Moo 4 Kuang Pei San Rd.
Re: Case ID # 300158
Dear Mr. Tohtubtiang:
We have evaluated your HACCP plans for “Mackerels/Sardines,” “Catfish/Clarias,” and “Baby Clams” you submitted to us in March 2012. Based on our review, your firm continues to have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). This letter explains the serious violations, provides a few additional comments, and provides our contact information.
You submitted these plans to FDA in response to a letter we sent you dated February 13, 2012. In our letter, we outlined problems in your seafood HACCP program there were noted during FDA’s inspection of your facility. The information that your firm provided to FDA in your March 2012 response is insufficient to show full correction to the problems.
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 fish and fishery 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 Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov. Also, the Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
Our concerns about your revised HACCP plans are as follows:
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(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, the revised HACCP plan provided for mackerels/sardines does not include processing steps as critical control points. Your processing steps should be handled as critical control points to ensure that time and temperature are controlled to prevent the hazard of histamine formation.
2. You must have a HACCP plan that as a minimum lists monitoring procedures and their frequencies for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s revised HACCP plan for mackerels/sardines lists monitoring procedures at the Receiving critical control point that are not adequate to control histamines. There is no indication that a representative number of fish will be monitored for histamine and for temperature.
Your plan indicates the use of an outside laboratory for the histamine testing. FDA does not recommend use of outside laboratories since the results may not be obtained within a reasonable timeframe to ensure that violative fish are not processed. If you choose to use an outside laboratory, you should ensure that the results accurately reflect the individual lots of fish and that the sample results can be obtained in a timely manner.
3. 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, the critical limits in your HACCP plans are not appropriate, as follows:
a. Your firm’s revised HACCP plan for mackerel/sardines does not list critical limits for sensory evaluation at the Receiving critical control point. FDA recommends conducting sensory evaluation on a representative number of fish with no more than 2.5% of the fish lot being decomposed.
b. Your firm’s HACCP plan for catfish/clarias lists only nitrofurans and malachite green residues as controls for unapproved aquaculture drugs. There are other drugs that can be reasonably likely to occur and that should be identified for control, such as fluoroquinolones and gentian violet.
4. Because you chose to include corrective actions 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 revised HACCP plan for mackerel/sardines at the Receiving critical control point to control histamines are not appropriate.
a. Your HACCP plan lists a corrective action of “In case of raw material contaminated with (b)(4) of histamine, separate the contaminated product and replace with new lot” for the control measure (b)(4). This correction action does not ensure that only those lots of fish properly handled onboard the vessels will be accepted by your firm for further processing. Scombrotoxin-forming fish with histamine levels (b)(4) should be rejected.
Your plan currently lists corrective actions for product that has (b)(4) at the receiving critical control point in your revised HACCP plan for mackerels/sardines. We believe this is a likely typographical error and should be (b)(4). If our belief is correct, this should be corrected in your plan.
b. Your HACCP plan lists the corrective action (b)(4) for the control measure (b)(4). (b)(4)potentially temperature abused product does not ensure that fish that are decomposed or that contain elevated histamine levels from the abuse will not be distributed into U.S. commerce. FDA recommends testing the product for decomposition and histamine when the original histamine levels were adequate, but the temperatures exceeded the critical limits. However, as noted above, when histamine levels exceed the critical limits at receiving, FDA recommends rejecting the entire lot.
We have one additional comment related to the use of undefined abbreviations or acronyms. The terms “AVL” and “MD” are referenced in the HACCP plan at the Receiving critical control point in your HACCP plan for “Catfish/Clarias.” However, it is unclear what these abbreviations stand for and this should be clarified in the plan.
We also note that your firm’s revised HACCP plans for mackerels/sardines, catfish/clarias, and baby clams list a critical limit “ensure the label contains the allergens” at the receiving label and packaging critical control point. A more appropriate critical limit for the allergen hazard would be “ensure product is labeled with the appropriate allergens.” “Ensure the label contains the allergens” could be used as a verification step for your final products.
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 such as HACCP and verification records, revised product labels, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, 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 seafood 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 regulations (21 CFR Part 123) is Import Alert #16-120. This alert can be found on FDA’s web site at: http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm.
This letter may not list all the violations 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 (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the U. S. Food and Drug Administration, Attention: Donald W. Greaves, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Mr. Greaves at (240) 402-2057 or via email at Donald.Greaves@fda.hhs.gov.
Office of Compliance
Center for Food Safety
and Applied Nutrition