| Public Health Service Food and Drug Administration |
Los Angeles District Pacific Region 19701 Fairland Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415 |
Department of Health and Human Services WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
W/L 30-11
Date: April 13, 2011
Jim (nmi) Lee, Owner
Hocean Food Corporation
1417 North Main Street
Los Angeles, CA 90012-1914
Dear Mr. Lee:
We inspected your rice noodle processing establishment, located at 1417 North Main Street, Los Angeles, California between November 29 and December 1, 2010. 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 and 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). In addition, failure to comply with the requirements on Part 110, renders all of your product, both fishery and non-fishery products adulterated within the meaning of Section 402(a)(4) of the Act.
Accordingly, your BANH CUON RICE ROLLED NOODLES with SHRIMP, a fishery product per 21 CFR 123.3(e), and other Rice Noodle products including BANH CUON RICE ROLLED NOODLES (without shrimp), BANH MONG Rice Noodle, and your BAHN PHO TUOI Pure Rice Noodle are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. In addition, we found your products to be misbranded under Section 403 of the Act, 21 U.S.C. §343 and the FOOD LABELING regulation, Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance, CGMP regulations for food, and labeling regulations for foods on FDA’s home page at www.fda.gov.
Based on your inspection and your FDA 483 response dated 12/08/2010, your significant violations were as follows:
SEAFOOD HACCP:
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 Rice Noodles with shrimp, which are made with real dried shrimp, to control the food safety hazards of pathogen survival through cooking,undeclared food intolerance substances such as sulfites, and metal inclusion.
Your hand-written one-page response dated 12/08/10 does not provide enough information to determine if your newly created HACCP plan is sufficient to control all the food safety hazards associated with this product. We will need to review and assess this document, and your implementation of the HACCP program during our next inspection.
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, on November 30, 2010, your firm did not monitor:
• safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice [21 CFR 123.11(b(1)]);
• condition and cleanliness of food contact surfaces [21 CFR 123.11(b)(2)];
• prevention of cross-contamination from insanitary objects [21 CFR 123.11(b)(3)] as evidenced by:
o two (2) cooking ladles used in contact with food contained rough welds. Some of these welds were observed to be discolored, and the rough welds make the equipment uncleanable.
o a white cloth with frayed, discolored edges came into direct contact with all of your Rice Noodle products as the cooked rice exited your (b)(4) steam tunnels.
• maintenance of hand washing, hand sanitizing, and toilet facilities [21 CFR 123.11(b)(4)];
• protection of food, food packaging material, and food contact surfaces from adulteration [21 CFR 123.11(b)(5)] as evidenced by:
o 15 drinking cups were observed above a processing room hand washing sink, and a drink dispenser is located next to the same hand washing sink on
o personal food items were being consumed in the production area during manufacturing operations. Specifically, an employee’s coffee cup was observed on a table located in the food production area.
o unlabeled Sodium Benzoate, an ingredient used in your Rice Noodle products, was stored in a container labeled (b)(4)
• proper labeling, storage and use of toxic chemicals; conditions [21 CFR 123.11(b)(6)] as evidenced by:
o three (3) chemical products were not properly identified with labeling and five (5) chemical products were not stored properly (b)(4) Crank Seal, (b)(4) Roach Bait, Paint Thinner, and Antifreeze/Coolant and (b)(4) Weed Killer). These products were found throughout the processing area, some stored directly next to food production utensils and equipment.
• control of employee health [21 CFR 123.11(b)(7)];
• and exclusion of pests with sufficient [21 CFR 123.11(b)(8)] as exhibited by:
o bird feces like filth too numerous to count were observed on bags of White Rice in (b)(4) your (b)(4) rice storage (b)(4).
We acknowledge your destruction of 78/100 lb. bags of white rice during the inspection that showed contamination from bird feces describe in item 2.A above, and also your written response dated 12/08/10 that indicated that you have corrected the other sanitation deficiencies described above. This written response is not adequate, however, since no verification of these corrections was supplied.
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 does not maintain any sanitation monitoring records for any of the eight key sanitation conditions and practices required for the processing of ready-to-eat BANH CUON Rolled Rice Noodles with Shrimp on days that you process this product. For example, you did not have sanitation monitoring records for this shrimp product that was being produced on 11/30/10.
We acknowledge your written response on 12/08/10 that indicates that you have begun creating and keeping sanitation control records. However, we do not find this response adequate since no verification was provided.
4. You must conduct all food manufacturing under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food, to comply with 21 CFR 110.80(b)(2). However, your current production procedures may contribute to contamination. Specifically, on November 30, 2010, you produced Rice Noodles with shrimp and then Rice Noodles without shrimp immediately afterwards on the same processing equipment. You did not clean and sanitize this equipment after producing the Rice Noodles with shrimp, or take any other measures to prevent the contamination of the Rice Noodles with allergenic shrimp proteins.
We acknowledge your written response on 12/08/10 that indicates that you have corrected this deficiency. However, we do not find this response adequate since no verification was provided. We cannot determine whether or not your corrections are adequate without additional information and/or verification of these corrections.
MISBRANDING
During the inspection, we obtained copies of your product labeling. Review of these labels revealed that several of your products are misbranded under section 403 of the Act [21 U.S.C. § 343].
Your BANH CUON Rolled Rice Noodle (with shrimp), BANH CUON Rolled Rice Noodle, BANH MONG Rice Noodle, and BAHN PHO TUOI Pure Rice Noodle products are misbranded under section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition fact panels are not declared in accordance with 21 CFR 101.9. Specifically, your products fail to declare trans fat as required in 21 CFR 101.9(c)(2)(ii). Your BANH CUON Rolled Rice Noodle with shrimp fails to round the sodium content to the nearest 5-mg increment [21 CFR 101.9(c)(4)] . Additionally, your BAHN PHO TUOI Pure Rice Noodle product fails to declare the number of servings per container in accordance with 21 CFR 101.9(b)(8)(i).
Your BANH CUON Rolled Rice Noodle (with shrimp), BANH CUON Rolled Rice Noodle, BANH MONG Rice Noodle, and BAHN PHO TUOI Pure Rice Noodle products are misbranded with the meaning of section 403(f) [21 U.S.C. § 343(f)] because your product labels contains information in two languages but does not appear to repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
We also note that your BANH CUON Rolled Rice Noodle (with shrimp) and BANH CUON Rolled Rice Noodle products declare “Total Card”; however it should be “Total Carb.”
We may take further action if you do not promptly correct these violations. For instance, we may seize your product(s) and/or enjoin your firm from further violating the Act.
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 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should respond in writing within 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.
We have an additional comment regarding your holding and distribution of your perishable Rice Noodle products mentioned above. As perishable foods which can support the rapid growth of undesirable microorganisms, particularly those of public health significance, these products must be held in a manner that prevents them from becoming adulterated within the meaning of the Act. Your current procedures of holding and distributing your hot noodle products without cooling may be contributing to potential microbial growth since they are likely held at ambient temperatures for prolonged periods of time. It is your responsibility to ensure that these products are cooled to refrigeration temperatures within a reasonable amount of time.
If you have any questions relating to this letter you should contact Robert B. McNab, Compliance Officer, at (949) 608-4409. Your written reply should be addressed to:
Blake Bevill, Director, Compliance Branch
U. S. Food and Drug Administration
19701 Fairchild Rd.
Irvine, California 92612
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District
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