Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm543202.htm
Timestamp: 2018-04-22 10:15:55
Document Index: 245988175

Matched Legal Cases: ['art 123', 'art 110', 'art 123', '§ 342', 'art 110', 'art 110', 'art 123', '§ 379', '§ 379']

Modern Macaroni Co Ltd 2/23/17
Telephone (510) 337 -6700
Aaron A. Rutledge, President
We inspected your seafood processing and food manufacturing facility, located at 1708 Mary Street, Honolulu, Hawaii 96819 between December 6 and 13, 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 products, Hula Brand Hana Ebi (artificially colored shrimp flakes) and Hula Brand Oriental Type Alimentary Paste Products, Udon and Somen, 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 FDA regulations, including the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
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. You must also 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 seafood product, Hula Brand Hana Ebi (artificially colored shrimp flakes) to control the food safety hazards of undeclared allergens (crustacean shellfish) and food and/or color additives (Sulfiting agents and FD&C Yellow #5).
a. FDA has identified crustacean shellfish (shrimp) as a major food allergen and consequently a food safety hazard that must be addressed in your HACCP plan.
b. Your bulk dried shrimp supplier’s invoice document indicates that this ingredient, used in your manufacturing of Hana Ebi products, may contain sodium bisulfite. FDA has identified sulfiting agents as a food intolerance causing substance and consequently a food safety hazard that must be addressed in your HACCP plan.
c. During your manufacturing process of Hana Ebi (artificially green-colored), you add FD&C Yellow No. 5. FDA has identified this color additive as a food intolerance causing substance and consequently a food safety hazard that must be addressed in your HACCP plan.
Please refer to Chapter 19 of the Fish and Fishery Products Hazards and Control Guidance (The Guide), Fourth Edition for additional information and guidance on hazard control strategies.
We acknowledge receipt of your response, dated December 26, 2016. In your letter, you agree that your firm has no HACCP plan in place. You included a statement that you will seek “further information regarding obtaining this HACCP plan” for your firm; however, your response is not adequate. You did not provide a timeframe of when a HACCP plan will be established and implemented, and your response does not provide assurances that your firm will process this product under an adequate HACCP plan.
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 specific 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 [21 CFR 123.11(b)(2)]
On December 6, 2016, our investigator observed the interior surfaces of your shrimp roaster and shrimp grinder, used to process your Hana Ebi, contained red colored shrimp residues. An employee told our investigator the equipment had last been used in October 2016, approximately two months prior to this observation.
In your December 26th response, you stated that your employees had thoroughly cleaned the interior and exterior of the roaster of dried red colored shrimp residue. However, your response is not adequate. Your response did not address the cleaning and condition of the shrimp grinder, which was the other piece of equipment colored residues were observed. Furthermore, you did not provide any corrective action to ensure this problem will not recur.
b. Maintenance of hand washing, hand sanitizing, and toilet facilities [21 CFR 123.11(b)(4)]
During our inspection, our investigator observed the hand washing sink located in the processing area lacked running water of suitable temperature for employees to adequately wash their hands, and the water running from this sink was not clear, but yellowish in color.
In your December 26th response, you stated that the “water level flow has been cleared so that the water is clear” and your employees were “told to use so that water does not sit and get that yellow coloring.” Your response is not adequate because it does not address correction to the water temperature.
c. Exclusion of pests from the food plant [21 CFR 123.11(b)(8)]
On December 6, 2016, our investigator observed the wooden shelves in your outside shrimp drying room contained green colored shrimp residues and apparent insect excrement.
In your December 26th response, you stated that the outside drying room was cleaned of the green shrimp residues as well as any droppings. However, your response is not adequate because you did not provide any corrective action to ensure this problem will not recur. You must take effective measurements to ensure pests are excluded from your food processing facility.
Current Good Manufacturing Practice (CGMP):
3. All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source, as required by 21 CFR 110.80. However, on December 6, 2016 during the manufacturing of Udon, our investigator observed your employee standing on top of a table adjacent to the dough hopper wearing street shoes, and a metal scrapper used to scrape in-process dough from the mixer into the hopper was stored on the table approximately ¼” away from the employee’s street shoes.
In your December 26th response, you stated you will move the hopper slightly away from the standing employee shoveling dough and that the scraper will be placed away from the surface of the hopper. We will verify the adequacy of your corrections during our next inspection.
4. No pests shall be allowed in any area of a food plant. Effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). However, on December 6, 2016, our investigator observed the following:
a. Apparent insect excrement, too numerous to count, were observed on a wooden ledge in the upstairs packing and storage area. Directly below the ledge were wooden crates storing unpackaged dried Somen.
In your December 26th response, you stated you have covered the ledge by placing a large blue tarp from the top to the bottom, and you have replaced the wooden shelves containing packed products with a metal shelf. However, you did not address how you will correct the termite problem in your food processing building and you did not provide the action you had taken to resolve the presence of the numerous insect excrements we observed during the inspection.
5. Equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained, as required by 21 CFR 110.40(a).
However, your firm uses wooden materials as direct food contact surfaces in the manufacturing of dried Udon and Somen. Our investigator observed in-process products were in direct contact with wooden racks, dowels, and crates, which were in disrepair, worn, and not easily cleanable.
In your December 26th response, you stated you plan to insert an acrylic-type of material inside the wooden crates and that you will cover the exposed sides and bottom of the wooden racks and wooden dowels with plastic, while you consider replacing the wooden dowels with plastic or PVC pipes. We remind you that it is your responsibility to ensure the materials you use in food production are suitable and appropriate as direct food-contact surfaces and are maintained in acceptable condition and adequately cleaned.
This letter may not list all the violations at your facility. You are responsible for ensuring you operate in compliance with the Act and all applicable regulations, including the seafood HACCP regulation (21 CFR Part 123), the Current Good Manufacturing Practice regulation (21 CFR 110) and food labeling regulation (21 CR 101). 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 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.
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 your HACCP plan 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 reference the CMS case # 517876 in your response.