WARNING LETTER
Hawaiian Ono Services, Inc. MARCS-CMS 514302 —
- Delivery Method:
- United Parcel Service
- Recipient:
-
Recipient NameSung Cha Ku
- Hawaiian Ono Services, Inc.
1111 Dillingham Boulevard Suite H6
Honolulu, HI 96817
United States
- Issuing Office:
- San Francisco District Office
United States
| Public Health Service Food and Drug Administration |
| San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: (510) 337-6700 |
Department of Health and Human Services
Via United Parcel Service
Signature Required
WARNING LETTER
January 10, 2017
Sung Cha Ku, Owner/President
Hawaiian Ono Services, Inc.
1111 Dillingham Boulevard Suite H6
Honolulu, HI 96817
Dear Ms. Ku:
We inspected your seafood processing facility, located at 1111 Dillingham Boulevard Suite H6, Honolulu, HI 96817 between December 8 and 9, 2016. 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 ready-to-eat tuna salad sandwiches, containing cooked tuna, 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 are 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 tuna salad sandwich products to control the food safety hazards of histamine, pathogen growth, allergens and metal inclusion.
Once you have conducted a hazard analysis for your seafood products, your HACCP plan must, at a minimum, list hazards that are reasonably likely to occur, and include appropriate critical control points, critical limits, monitoring procedures, recordkeeping activities, etc., to ensure that the food safety hazards are controlled to comply with 21 CFR 123.6(c).
Please refer to the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition (the Hazards Guide), including Chapter 7 (Histamine Formation), Chapter 12 (Pathogenic Bacteria Growth and Toxin Formation as a Result of Time and Temperature Abuse), Chapter 19 (Undeclared Major Food Allergens), and Chapter 20 (Metal Inclusion) for guidance in determining the appropriate controls for your processing operations.
2. 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 the condition and cleanliness of food contact surfaces and prevention of cross-contamination from insanitary objects with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
a. On December 8, 2016, our investigator observed the use of quaternary ammonium chloride sanitizing solution of 0 ppm as a sanitizer for food contact surfaces and utensils. The sanitizer was not effective at that concentration.
b. On December 8, 2016, our investigator observed one employee touching non-food contact surfaces, such as his eyeglasses, with his bare hands and then, without washing and/or sanitizing his hands, held the ready-to-eat tuna salad sandwiches during packing.
c. On December 8, 2016, our investigator observed two employees whose hair were not fully covered in hair restraints while preparing and packing ready-to-eat sandwiches, including tuna salad sandwich.
Similar observations of poor employee hygienic practices have been made during our previous inspections of your facility.
3. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for 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; protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemicals; control of employee health conditions; and exclusion of pests required for the processing of your tuna salad sandwich products on, at least, December 8, 2016. The same observation was made during our previous inspection of your facility.
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, 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.
(b)(3)(A)
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 mean all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the inspection and assessing and collecting the 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.
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:
Attention: Lawton W. Lum, Director, Compliance Branch
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
Refer to the Unique Identification Number CMS Case #514302 when replying.
If you have questions regarding any issues in this letter, please contact Lydia S. Chan, Compliance Officer, at Lydia.chan@fda.hhs.gov or (510) 337-6776.
Sincerely,
/S/
Darla R. Bracy
Acting District Director