Inspections, Compliance, Enforcement, and Criminal Investigations
Amor Nino Foods Inc 5/11/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700
UPS OVERNIGHT DELIVERY
May 11, 2012
Our Reference # 1000123930
Mr. Amor B. Nino, President
Amor Nino Foods Inc.
1928 Homerule St.
Honolulu, Hawaii 96819
Dear Mr. Nino:
We inspected your seafood processing facility located at 1928 Homerule St., Honolulu, Hawaii between the following dates: February 28 to March 16, 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 (21 CFR 123). 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 Dried Aku 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 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 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 plan for Dried Aku does list the food safety hazard of histamine formation which is reasonably likely to occur during receiving, thawing, brining, drying, and refrigerated storage. In addition, your HACCP plan for Dried Aku does not list the food safety hazard of pathogen growth and toxin formation, namely Staphylococcus aureus, which is reasonably likely to occur during drying.
Please refer to Chapter 7 and 14 of the Fish and Fisheries Products Hazards & Control Guidance, Fourth Edition for additional information related to controlling histamine formation and pathogen growth and toxin formation as a result of inadequate drying. You can find an electronic copy of the Guidance at the following web address: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
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 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) Condition and cleanliness of food contact surfaces – FDA investigators observed that the large white plastic bins used to store frozen, fresh, and thawing whole skipjack tuna were found to contain a significant amount of dirt, grime, and residue build-up.
(b) Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garment, and from raw product to cooked product – FDA investigators observed an employee touch the door, door handle, and door jam leading from the smoker room to the warehouse. The employee then began hand packing finished ready-to-eat Dried Aku without washing or using gloves.
(c) Protecting food, food packaging material, and food contact surface from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants – FDA investigators observed a bin containing whole skipjack tuna stored in the processing room directly underneath the air conditioning unit. Condensate from the air conditioning unit was observed dripping directly onto the tuna.
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 the safety of water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice, and the proper labeling, storage, and use of toxic compounds required for the processing of Dried Aku, a ready-to-eat product.
The above violations are not intended to be an all-inclusive list of violations at your firm.
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 Lawton W. Lum, Director of Compliance at 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have questions regarding any issues in this letter, please contact Brandon L. Bridgman, Compliance Officer, at (510) 337-6794.
Barbara J. Cassens
San Francisco District
U.S. Food and Drug Administration
Food and Drug Branch
Hawaii Department of Health