Inspections, Compliance, Enforcement, and Criminal Investigations
Taiyo Seafood, Inc 10/25/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Baltimore District Office|
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5705
Return Receipt Requested
October 25, 2013
Ms. Su Chen, Owner
Taiyo Seafood Inc.
7190 Oakland Mills Rd.
Columbia, MD 21046
Dear Ms. Chen:
From August 13 through August 29, 2013, we inspected your seafood processing facility located at 7190 Oakland Mils Road, Columbia, MD. We found that you have serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) Regulations, Title 21, Code of Federal Regulations, Part 123 (21 CPR 123). In accordance with 21 CPR 123.6 (g), failure of a processor offish 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 regulations and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
The FDA investigator provided you with a copy of the FDA 483, Inspectional Observations, which presents their evaluation of your firm's performance regarding various aspects of the HACCP requirements. The deviations were as follows:
1. You must conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish or fishery product that you process, 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). 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 does not have a HACCP plan for Tuna to control the food safety hazard of histamine formation, or Salmon to control the food safety hazard of Pathogen bacteria growth-temperature abuse.
2. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123. 7(a), and (b). Your firm did not take a corrective action to control the Clostridium botulinum hazard for Pasteurized Crabmeat. It was observed that 80 cases of Pasteurized Crabmeat were being stored in a cooler being held at 52.8°F and the internal temperature of one can of crabmeat was 48.3°F. Additionally the temperature recording chart in this cooler showed that the cooler temperature was above 40°F for approximately 15 hours.
3. 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). You must also implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). You are not implementing the monitoring, recordkeeping, and verification procedures listed in your HACCP plan(s), as evidenced by:
a. Your HACCP plan for Pasteurized Crabmeat lists a monitoring activity of (b)(4) checking the temperature of a representative number of pasteurized crabmeat containers per shipment at the receiving CCP, and documenting this check on the crabmeat receiving record. During the inspection, more than 80 cases of pasteurized crab meat were being stored with no records of the products having been received, or evidence that this monitoring activity was conducted.
b. Your HACCP plan for Histamine-prone fish species lists a monitoring activity of (b)(4) checking the temperature chart recorder (b)(4) for the storage CCP, and documenting this check on the refrigeration temperature record. Your Cooler and Freezer Temperature Record does not include a temperature check for the cooler where ready-to-eat tuna is stored. Furthermore, you do not have a temperature chart recorder in the cooler where ready-to-eat tuna is stored.
c. Your HACCP plans for Histamine-prone fish species and Pasteurized Crabmeat list "(b)(4) calibrate thermometer or agitated ice slush" as a verification procedure for the receiving and storage CCP's. The calibration ofthermometers was not conducted between April 22, 2013-July 22, 2013.
4. 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).
a. Your HACCP plan for Pasteurized Crabmeat lists a verification procedure of (b)(4) reviewing shellfish transfer records and corrective action records, and (b)(4) calibrating thermometers or agitated ice slush at the receiving and storage CCP's. This verification procedure lists a frequency of thermometer calibration which does not ensure adequate monitoring of cooler temperatures, and does not include the review of monitoring records, calibration records, and complaint records.
b. Your HACCP plan for Histamine-prone fish species lists a verification procedure of (b)(4) reviewing records and corrective action records, and (b)(4) calibrating thermometer or agitated ice slush at the receiving and storage CCP's. (b)(4) temperature verification is not conducted, and your verification procedures do not include the review of complaint records and calibration records.
c. Your continuous temperature recorder, which is used to monitor Cooler # 2 which stores crab meat is not checked to verify that it is working properly or calibrated to ensure its accuracy. The calibration ofthermometers was not conducted between April 22, 2013-July 22, 2013, and was not checked to verify that they were working properly. These thermometers are used to document the temperature of Coolers # 1, and #2, where crabmeat is stored and ready-to-eat tuna is filleted.
5. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your firm's HACCP plans for Pasteurized Crabmeat and Histamineprone fish, lists monitoring procedures and frequencies that do not ensure compliance with the critical limit, as evidenced by:
a. Your HACCP plan for Pasteurized Crabmeat lists a monitoring procedure of (b)(4) checking the temperature at least (b)(4) at the storage CCP.
b. Your HACCP plan for Histamine-prone fish species lists a monitoring procedure of (b)(4) checking that the product is surrounded with ice upon receipt of each shipment at the receiving CCP. However, the critical limit listed for this CCP is "Receive only product at a temperature of 40°F or less", and does not mention the adequacy of ice.
c. Your HACCP plan for Histamine-prone fish species lists a monitoring procedure of (b)(4) checking the temperature chart recorder (b)(4) at the storage CCP. However, the critical limit listed for this CCP is "Fish kept at a temperature of 40°F or less and completely surrounded with ice." Furthermore, you do not have a continuous temperature chart recorder in the cooler where ready-to-eat tuna is stored.
d. Your HACCP plan for Histamine-prone fish species lists a corrective action plan of adding ice if the amount of ice is not adequate for the storage CCP. This corrective action plan does not address the cause of the deviation.
6. You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following eight areas of sanitation with sufficient frequency to ensure control as evidenced by:
a. Safety of Water: You do not have a backflow prevention device for the hose used to clean whole, ready-to-eat tuna prior to filleting. The hose was observed being inserted inside of the tuna to rinse it, as well as for rinsing the outside of the tuna. The hose is also used to rinse food contact surfaces and the production room. The same hose is stored by placing the nozzle inside the three-compartment sink in the production room.
b. Conditions and Cleanliness of Food Contact Surfaces:
i. You use (b)(4) soap and water to clean food contact surfaces, and do not use sanitizer to clean food contact surfaces, including cutting boards, tables, and scales which are used to fillet, store, and weigh tuna during production.
ii. The ice shovel used to add ice to fish stored in the cooler was observed stored both inside the ice maker and on the floor on August 13, 2013.
iii. (b)(4) is used to hold ready-to-eat tuna on the scale in the production room. On August 13, 2013, the (b)(4) appeared to be dirty, and is not made of a material that can be adequately cleaned.
c. Protection from Adulterants:
i. Condensation was observed in the cooler where ready-to-eat tuna and ready-to-eat salmon are stored, in the production room where ready-to-eat tuna is filleted, and at the doorway between the two rooms. During the defrost cycle, the cooling unit in the cooler where readyto- eat tuna and ready-to-eat salmon are stored was observed to be streaming water onto (b)(4) boxes filled with ready-to-eat salmon.
ii. Cooler # 2 was observed to have a temperature of 52.8°F. Over 80 cases of pasteurized crabmeat were being stored at this time. The internal temperature for one can of crabmeat was 48.3°F using an FDA calibrated thermometer. The temperature recording chart in this cooler is not reviewed, and thermometers used to check the temperature of this cooler are not calibrated.
iii. Tuna buildup was observed around cutting boards and on floor mats. The cutting boards are not removed from the tables they sit on during the sanitation process.
iv. Floors entering into the production area allow for the pooling of water.
d. Labeling, Storage, and Use ofToxic Chemicals: The sanitizing solution of water and bleach registered at 0 ppm chlorine. Your firm is not testing the concentration of sanitizer at any time during processing or after sanitation, and does not document sanitizer concentrations on the Daily Sanitation Control Records.
7. You must have an individual associated with your firm who has successfully completed training in the application of HACCP principles to fish and fishery product processing at least equivalent to that received under standardized curriculum recognized as adequate by the FDA, or is otherwise qualified through job experience, as required by 21 CFR 123.10. However, your firm failed to have an individual who has successfully completed appropriate HACCP training, or who is otherwise qualified through job experience.
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.
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 the seafood HACCP regulation (21 CFR Part 123). 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-1(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 ofthe Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
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.
Please send your reply to the Food and Drug Administration, Attention: Mrs. Evelyn Bonnin, District Director, 6000 Metro Drive, Suite 1 01 , Baltimore, MD 21215. If you have questions regarding any issues in this letter, please contact Mr. Ernie Bizjak, Compliance Officer at 410-779-5715 or via email at Emest.Bizjak@fda.hhs.gov.