Inspections, Compliance, Enforcement, and Criminal Investigations
Taiyo Seafood Boston Inc. 6/21/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District
CMS # 317818
VIA UPS OVERNIGHT
June 21, 2012
Mr. Jackie Zheng, Owner
Taiyo Seafood Boston Inc.
256 Arlington St
Quincy, MA 02170-1724
Dear Mr. Zheng
We inspected your seafood processing facility, located at 256 Arlington Street on May 10 to May 23, 2012. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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 insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
We have reviewed your firm’s signed and dated 06/08/12 response and note that it lacks sufficient corrective actions.
Specific violations observed during the inspection include, but are not limited to, the following:
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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for each fish or fishery product with identified hazards including, but not limited to:
Raw, refrigerated Spanish mackerel to control the food safety hazards including species related hazards scombrotoxin formation and parasites as the product is intended to be consumed raw in addition to process-related hazard pathogenic bacteria growth and toxin formation.
Raw, refrigerated vacuum packaged yellowtail to control the food safety hazards including species-related hazard scombrotoxin formation in addition to process-related hazard Clostridium botulinum toxin formation as the product is processed into reduced oxygen packaging and pathogenic bacteria growth and toxin formation.
2. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control the food safety hazards of scombrotoxin and pathogenic bacteria growth and toxin formation when your process for raw refrigerated tuna deviated from your critical limit at (b)(4) the critical control point. Your HACCP plan states that fish are to be completely surrounded by ice at the (b)(4) critical control point, and the corrective action states that fish is to be rejected if it is not surrounded by ice. However, on at least seven different dates since April 2, 2012 we observed that the Tuna Receiving Log indicates your firm received and accepted tuna packed with no ice at all. There are no records that indicate any corrective actions were taken.
3. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the (b)(4) critical control point to control the food safety hazards of scombrotoxin and pathogenic bacteria growth and toxin formation listed in your HACCP plan for raw refrigerated tuna. Tuna Receiving Logs dated 03/12/2012 through 05/07/2012 do not capture the number of containers examined or the adequacy of ice for each.
4. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm does not follow the monitoring frequency of (b)(4) verifying the adequacy of ice surrounding products and ensuring the cooler temperature is a minimum of 40 degrees Fahrenheit at the (b)(4) critical control point to control the food safety hazards of scombrotoxin and pathogenic bacteria growth and toxin formation listed in your HACCP plan for raw refrigerated tuna. Your firm operates Monday thru Friday and is closed on Saturday and Sunday when no monitoring activities are performed.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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. You should include in your response documentation such as HACCP and verification records, 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.
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, 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 Act and all applicable regulations.
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. Are-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 there-inspection and assessing and collecting there-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic 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 send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, One Montvale Ave., Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 802-868-4 725 X 109.
Mutahar S. Shamsi
New England District