Inspections, Compliance, Enforcement, and Criminal Investigations
Mitsutoyo Co. Ltd., Hakodate Plant 3/4/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
March 4, 2013
VIA EXPRESS DELIVERY
Mr. Yasunari Shioda, Director
Mitsutoyo Co. Ltd.
Reference No. # 392927
Dear Mr. Shioda:
We inspected your seafood processing facility, Mitsutoyo Co. Ltd. Hakodate Plant, 2-8, Oiwake 4-chome, Hokuto, Hokkaido, Japan 049-0101 on November 15 and 16, 2012. 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). That 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 14, 2012 response that provided the descriptions of your corrective actions to the observations of concern noted on the FDA-483. Your December 14th response included a revised HACCP plan, and processing records. 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 prepared squid 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. The 4th Edition of the Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
Your significant deviations 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(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 prepared squid provided with your response does not list the critical control point associated with the primary aging step, for controlling the food safety hazard of pathogen growth and toxin formation. Specifically, our investigator noted that there are (b)(4) steps as part of your processing operations, a (b)(4). While your firm has included the (b)(4) step in your plan, your firm needs to also include a critical control point for the (b)(4) step to control pathogen growth as a result of time and temperature abuse in your ready to eat squid product.
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 firm’s revised HACCP plan for frozen ready to eat prepared squid provided with your response lists critical limits at the (b)(4) critical control points that are not adequate to control pathogen growth. Specifically, at the:
- (b)(4) critical control point, your firm lists “Temp: (b)(4); Time: (b)(4).” However, the listed temperature critical limit of (b)(4) is inadequate because the product is held for an extended period of time (i.e. (b)(4)) at this temperature. FDA recommends maintaining ready to eat products such as your frozen ready to eat prepared squid at refrigerated temperatures of 40°F (4.4°C) or below throughout the defrosting process or that the product be held on ice to prevent pathogen growth as a result of time and temperature abuse.
- (b)(4) critical control point, your firm lists “Temp: (b)(4); Time: (b)(4).” However, the listed temperature critical limit of (b)(4) is inadequate because the product is held for an extended period of time (i.e. (b)(4)) at this temperature. FDA recommends maintaining ready to eat products such as your frozen ready to eat prepared squid at cooler or ambient air temperatures of 40°F (4.4°C) or below for the duration of the aging process to prevent pathogen growth as a result of time and temperature abuse.
3. 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 prepared squid provided with your response does not list a corrective action at the Label critical control point appropriate to control the food safety hazard of Clostridium botulinum growth and toxin formation. Your firm’s frozen prepared squid is packaged in a reduced oxygen plastic bag which may create an anaerobic environment conducive for Clostridium botulinum to 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 monitor each batch of labels (or packages) to ensure that the handling instructions are included on the labels.
We do not recommend end product testing for the presence of pathogens as part of a corrective action plan. This is because it is not an effective means of ensuring the safety of the entire lot of product exposed to potential time and temperature abuse. FDA recommends evaluating the time and temperature exposures above 40°F or the time exposures when not properly iced. Additionally, FDA recommends that affected products are discarded or diverted to non-food use.
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