- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
JUL 7, 2014
VIA EXPRESS DELIVERY
Toshiaki Aihoshi, President
Reference # 432549
Dear Mr. Aihoshi:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility Marutoshi located 1-46-1 Komatsubara, Kagoshima-shi, Japan on March 17-18, 2014. During that inspection, we found that you had violations of the seafood Hazard Analysis 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 observations made at your firm.
We acknowledge receipt of your response sent via email on May 10, 2014. Your response included a revised HACCP plan dated April 9, 2014, blank monitoring records, a laboratory report and a written corrective action plan. However, review of the documentation revealed 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 Bonita tuna flake products 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 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, your firm’s revised HACCP plan dated April 9, 2014 for Bonita tuna flake does not list a critical control point for “(b)(4)” of the Bonita tuna flakes necessary to control the identified hazard of pathogenic bacteria. During the inspection, your firm was observed (b)(4). FDA recommends that your firm include a critical control point for storage at a critical limit temperature of 40°F (4.4°C) or less using equipment capable of continuously monitoring and recording the time and temperature.
2. Corrective action plans when included in HACCP plans must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan in your revised HACCP plan for “Bonita tuna flakes” does not ensure that the cause of the critical limit deviation is corrected at the critical control point of “(b)(4).” Specifically, the listed corrective action of “(b)(4)” is not adequate because it does not address correction of the process deviation. FDA recommends when a deviation occurs during the drying process the firm make the appropriate adjustments to the drying process in addition to disposition of the affected product.
You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.8(a). However, your firm does not include a target value for the water activity testing at the “(b)(4). When using critical factors like time and temperature for the drying procedure as the critical limits for shelf stable dried products, FDA recommends processors conduct water activity analysis on finished product to ensure that the processing procedures in fact achieve a final water activity level of 0.85 or below and that this is conducted at least every three months.
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 revised HACCP plan, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of five 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 Food and Drug Administration, Attention: Standra Purnell, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Purnell via email at email@example.com.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition
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