| Public Health Service Food and Drug Administration |
| Chicago District 550 West Jackson Blvd. 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863 |
Department of Health and Human Services
October 13, 2011
WARNING LETTER
CHI-1-12
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Jang Hoee Kim
President
True World Foods, LLC.
32-34 Pepetti Plaza
Elizabeth, NJ 07206
Dear Mr. Jang Hoee Kim:
We inspected your seafood processing facility, located at 950 Chase Avenue, Elk Grove Village, Illinois, on March 8, 2011 through May 6, 2011. 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 refrigerated and raw, Ready-To-Eat (RTE) seafood products, are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they 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.
Your significant violations were as follows:
- 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 HACCP plans for:
- “Fresh Ocean Harvested HACCP Plan” (HACCP (b)(4)) and “Ocean Harvested Fresh, Frozen Fish, and Shellfish” (HACCP (b)(4)) do not list the food safety hazards of:
o Parasites, which is associated, at a minimum, with the Aji (Mackerel), Aku (Skipjack Tuna), Kanpachi (Skipjack Tuna), Amberjack, Trevally, and Mackerel spp., Akauo (Ocean Perch), and which are reasonably likely to be consumed raw.
o Undeclared allergens, which is associated with all finfish and crustacean species.
o Clostridium botulinum, which is associated with frozen vacuum packed seafood covered under (b)(4). FDA currently recommends that processors establish a CCP to assure that all individual packages are clearly labeled with safe handling instructions. Other refrigerated goods in oxygen limiting packaging, such as smoked fish or pasteurized crabmeat, may also be associated with the hazard and require the implementation of controls.
- Farm Raised Fish and Shellfish (HACCP (b)(4)) and Fresh Farm Raised Fish (HACCP (b)(4)) do not list the food safety hazards of:
o Undeclared allergens, which is associated with all finfish and crustacean species. FDA recommends that processors establish a critical control point to assure that their products are accurately labeled.
o Clostridium botulinum, which is associated with frozen vacuum packed seafood covered under (b)(4). FDA currently recommends that processors establish a CCP to assure that all individual packages are clearly labeled with safe handling instructions. Other refrigerated goods in oxygen limiting packaging, such as smoked fish or pasteurized crabmeat, may also be associated with the hazard and require the implementation of controls.
- 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 HACCP plan for:
- “Ocean Harvested Fresh, Frozen, Frozen Vacuum Packed” (HACCP (b)(4)), “Farm Raised Fish and Shellfish” (HACCP (b)(4)), “Farm Raised Fish” (HACCP (b)(4)), and “Ocean Harvested Fresh, Frozen Fish”, and Shellfish (HACCP (b)(4))
o list a critical limit (b)(4) or (b)(4) at the Receiving Critical Control Point that is not adequate to control the food safety hazards of scombrotoxin formation and pathogen growth/toxin formation associated with some of the seafood products covered by these plans. The critical limit does not define “adequate”. FDA currently recommends that ice or cooling media surround the product.
o The plan fails to list a critical limit for internal temperatures. When receiving refrigerated products under cooling media, (e.g. gel packs), processors should also monitor the internal temperatures of a representative number of product units.
- “Ocean Harvested Crab” (HACCP (b)(4)) lists a critical limit, "The product must not be exposed to a (b)(4) and (b)(4) that will allow growth of C. Botulinum”, at (b)(4) critical control point that is not adequate.
o Specifically, the critical limit does not specify an actual limit. FDA currently recommends that a critical limit of 40°F. The consideration of time/temperature exposures is more appropriately done as a corrective action when that temperature critical limit is exceeded.
o In addition, your firm also appears to receive product transported less than four (4) hours. FDA recommends that in addition to listing a critical limit for internal temperatures, the plan should also include critical limits and monitoring procedures to assure that product is not transported longer than four (4) hours.
o Your monitoring procedures indicate that (b)(4) will be monitored, but do not list a critical limit for them. In addition, if you choose to monitor the adequacy of (b)(4), your firm should also take internal temperatures of a representative number of samples.
- 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 did not follow the monitoring procedures of (b)(4) critical control point to control C. botulinum and pathogen growth listed in your HACCP plan for “Ocean Harvested Crab” (HACCP (b)(4)). Specifically, the Receiving Logs document one product temperature per item line. Our investigator observed documentation that the transit time is greater than four (4) hours and the product is not received on ice or other cooling media. Your records did not document the internal temperature of the fish while in transit or maintain records of the temperature of the truck or other carrier throughout transportation.
In addition, please be aware that by listing “OR” between different monitoring procedures you provide the option of selecting one of the listed controls. This may not be acceptable in all situations.
- You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, and protection of food, food packaging material, and food contact surfaces from adulteration with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
- The water to the three compartment sink in the production room is conveyed to the sink using black laundry washing machine hoses.
- On 03/25/11, large gray plastic totes were observed being used in the cooler. A lid from one of these totes was observed to be sitting bottom side down on top of Styrofoam boxes that salmon were shipped in and the tote left open. Ice from these totes was put directly on top of fish in the cooler.
- On 05/04/11, an employee not wearing gloves and who did not wash his/her hands upon entering the production room was observed in the production room handling a plastic bag which was put into a corrugated box. Finished product was then placed into the plastic bag and the bag and box were sealed, labeled (b)(4), and put on a metal rack with other product to be distributed.
- Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b).
- However, your corrective action plan for “Fresh Ocean Harvested Plan” (HACCP (b)(4)); “Farm Raised Fish and Shellfish” (HACCP (b)(4)); “Farm Raised Fish” (HACCP (b)(4)); and “Ocean Harvested Fresh, Frozen Fish and Shellfish” (HACCP (b)(4)) at the Receiving critical control point to control pathogen growth and toxin formation is not appropriate. Specifically, the corrective action of (b)(4) is not acceptable if the critical limit is not met. Additionally, the corrective action does not list acceptable controls for scombrotoxin forming species. Histamine testing should be conducted on a minimum of 60 fish.
- However, your corrective action plan for “Fresh Ocean Harvested Plan” (HACCP (b)(4)) at the Thawing critical control point to control Pathogen growth and toxin formation is not appropriate. The corrective action lists (b)(4) and (b)(4). However, temperatures are only monitored at the start and end of the thaw process. In some instances, this evaluation cannot provide the information necessary to determine time/temperature exposures.
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.
Please send your reply to the U.S. Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, 550 West Jackson Boulevard, 15th Floor, Chicago, Illinois 60661-5716. If you have questions regarding any issues in this letter, please contact Ms. Sexton at 312-596-4225.
Sincerely,
/S/
Scott J. MacIntire
District Director
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