Inspections, Compliance, Enforcement, and Criminal Investigations
Sea One Enterprises, Inc. 8/29/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Cincinnati District Office|
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
August 29, 2012
United Parcel Services
Mr. John K. Yim, Vice-President/Owner
Sea One Enterprises, Inc.
7307 Young Drive #C
Walton Hills, OH 44146-5385
Dear Mr. Yim:
We inspected your seafood processing facility, located at 7307 Young Drive Ste C, Walton Hills, OH 44146 on June 19, 20, 27, 28 and July 3, 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 raw, ready-to-eat 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:
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 your ready to eat salmon and ready to eat rockfish (bass) to control the food safety hazard of pathogen growth and toxin formation.
2. 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 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, physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plan for raw, ready-to-eat yellowfin tuna does not list the food safety hazard of pathogen growth and toxin formation.
3. You must monitor sanitation conditions and practices 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 the following areas of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
a. Prevention of cross contamination from insanitary objects to food packaging material and other food contact surfaces
i. A pallet of ready-to-eat tuna was observed on a pallet 5” high off the ground resting in pooled water in the walk-in cooler.
ii. Old, molded and soiled boxes containing seasoned Burdock was stored above newly processed ready to eat tuna loins in the walk-in cooler.
iii. Doorway curtains encrusted with brown build-up, grime and food. Employees were observed touching the doorway curtains and other non-food contact surfaces and back to touching raw, ready-to-eat fish with no hand washing and/or glove changes.
b. Protection of food from adulteration
i. Raw, ready-to-eat tuna being weighed on a used Styrofoam box that was previously used for Salmon.
ii. The water hose used to rinse the food preparation table, cutting board, walls and 3-compartment sink splashed water atop raw, ready-to-eat tuna stored on the processing room floor.
c. Condition and cleanliness of food contact surfaces
i. FDA observed that the cutting boards used to process raw, ready-to-eat tuna were deeply gouged and stained with debris.
ii. FDA observed a brown build-up on your ice scoop, ice shovel, and ice bin used on raw, ready-to-eat fish.
d. Maintenance of hand washing, hand sanitizing and toilet facilities
i. No soap or hand towels at the processing room hand sink.
Your firm has been cited for similar sanitation deviations since 2009.
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 did not follow the monitoring procedure of visually checking ice twice day at the storage critical control point to control scrombrotoxin (histamine) formation listed in your HACCP plan for tuna. Specifically, your firm is not visually checking the adequacy of ice twice daily when your firm is closed on weekend and holidays.
5. 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 your raw, ready-to-eat tuna storage critical control point to control scombrotoxin formation is not appropriate. Your corrective action states to “ move product to a functioning cooling unit”, when your firm only has one cooler.
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 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.
We may take further action if you do not promptly correct these violations. Failure to correct these violations in a prompt manner may result in regulatory actions without further notice, such as seizure, injunction and/or prosecution.
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 Food and Drug Administration, Attention: Allison C. Hunter, Compliance Officer, 6751 Steger Drive, Cincinnati, OH 45237. If you have questions regarding any issues in this letter, please contact C.O. Hunter at 513-679-2700, Extension 2134.
Cincinnati District Director