Kanetoku Corporation 2/13/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD 20740
February 13, 2013
VIA EXPRESS DELIVERY
Mr. Shoji Tomiyama, Factory Manager
Hyogo Pref., Japan
Reference No. # 392714
Dear Mr. Tomiyama:
We inspected your seafood processing facility, Kanetoku Corporation, Sasayama Factory, Izumi Complex, Sasayama-shi, 669-2406, Hyogo Pref., Japan, on November 8 and 9, 2012. During that inspection, we found that you 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 inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your December 12, 2012 response that provided the description of your corrective actions to the observations of concern noted on the FDA-483 issued at the conclusion of the inspection, revised HACCP plan, and Hazard Analysis. We have assessed the response and have continuing concerns 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 frozen, ready-to-eat capelin roe (prepared capelin roe or masago) are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
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 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 revised HACCP plan for frozen, ready-to-eat capelin roe provided with your response does not list the food safety hazard of Clostridium botulinum. Based on our inspection, you are packing your roe in 5kg plastic bags. The food safety hazard of Clostridium botulinum growth and toxin formation is associated with large and deep packaged products which may create an anaerobic environment in which Clostridium botulinum can proliferate and produce toxin. FDA recommends that all finished frozen product packages include handling instructions to control the hazard of Clostridium botulinum growth and toxin formation by including a statement such as “Keep Frozen”, “Thaw under Refrigeration Immediately Prior to Use”. We further recommend that firms include a critical control point to monitor each batch of labels (or packages) to ensure that the handling instructions are included on the labels.
2. 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 Part 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 revised HACCP plan for frozen, ready-to-eat capelin roe provided with your response does not list the critical control points for unrefrigerated processing steps, other than thawing, to include (b)(4) for controlling the listed food safety hazard of pathogen growth and toxin formation.
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, your firm’s revised HACCP plan for frozen, ready-to-eat capelin roe provided with your response lists critical limits at the “Thawing” critical control point that are not adequate to control pathogen growth. Specifically, your firm lists “Raw material is soaked in water frozen. After thawing, the temperature of it must be kept (b)(4). Thawing time is within 18 hours at maximum.” However, the listed temperature critical limit of (b)(4) is inadequate because the product is held for an extended time period (b)(4) at this temperature. FDA recommends that when holding time periods are as long as 18 hours that the product be held under refrigerated conditions at temperatures of 40°F or below; or that the product be held on ice to prevent pathogen growth and toxin formation. Additionally, FDA recommends that you monitor and record the time and temperature throughout the duration of the thawing step continuously using a time and temperature recording device; or at a minimum every 2 hours. Or that you monitor the presence of adequate ice surrounding the product at a frequency to ensure that the products are maintained at adequate temperatures to control pathogen growth and toxin formation.
4. Since 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, your firm’s revised HACCP plan for frozen, ready-to-eat capelin roe provided with your response lists a corrective action at the Thawing critical control point that is not appropriate to control the food safety hazard of pathogen growth. Specifically, the corrective action of “The product is suspended. It is judged based on the result of the germ’s examination” is not appropriate in that germ’s examination does not ensure that no product that is either injurious to health or is otherwise adulterated enters commerce. Moreover, we do not recommend testing products for the presence of pathogens as a corrective action when products have been exposed to potential time and temperature abuse. Additionally, the corrective action must also ensure that the cause of the deviation is corrected. FDA recommends that the evaluation of the product’s safety be based on the time and temperature exposures above 40°F or when not properly iced, and that affected products are discarded or diverted to non-food use.
5. You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6 (c)(4).However, your firm’s revised HACCP plan for frozen, ready-to-eat capelin roe provided with your response lists a monitoring frequency of (b)(4) or less) critical control point that is not adequate to control the food safety hazard of pathogen growth and toxin formation. FDA recommends that you continuously monitor and record the times and temperatures during refrigerated storage using a continuous temperature recording device and perform a daily visual check of the generated data.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations to include but not limited to: a copy of any revised HACCP plan or plans; at least five (5) product days worth of monitoring records (i.e., complete production days) to demonstrate that you have implemented the revised plan or plans; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen 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
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, 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.
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 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. You should consider providing your US Agent with a copy of this letter.
Please send your reply to Food and Drug Administration, Attention: Maria Corpuz, 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 this letter, you may contact Ms. Corpuz via email at Maria.Corpuz@fda.hhs.gov
Office of Compliance
Center for Food Safety
and Applied Nutrition