Inspections, Compliance, Enforcement, and Criminal Investigations
Foo Yuan Food Products Co., Inc 10-Jul-07
Department of Health and Human Services
Public Health Service
New York District
July 10, 2007
RETURN RECEIPT REQUESTED
Foo Yuan Food Products Co., Inc.
23-01 Borden Avenue
Long Island City, New York 11101
Dear Mr. Chuang:
We inspected your seafood processing facility, located at 23-01 Borden Avenue, Long Island City, New York 11101, on February 28, 2007 and March 1-2, 5, 9, 22-23, 2007. 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 cooked vacuum packaged refrigerated/frozen ready-to-eat fish balls and cooked vacuum packaged refrigerated/frozen ready-to-eat fish cakes 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 serious violations from the food labeling regulations (21 CFR 101) on the labels for your Fried Fish Cake (7oz), Fish Ball (7oz), and Fried Fish Ball (6oz) products. You may find the Act, the seafood HACCP and food labeling regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant HACCP and sanitation violations were as follows:
I. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you process 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 cooked vacuum packaged refrigerated/frozen ready-to-eat fish balls and cooked vacuum packaged refrigerated/frozen ready-to-eat fish cakes, which you manufacturer and store, to control the food safety hazards of pathogen survival through cooking, pathogen growth and toxin formation, including Clostridium botulinum toxin formation.
II. You must adequately monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110 and to comply with 21 CFR 123.11(b).
1. However your firm did not adequately monitor the prevention of cross-contamination as evidenced by our observation that workers were handling cooked ready-to-eat products prior to vacuum packaging without hand washing and sanitizing and without using gloves.
2. Your firm did not adequately monitor the conditions and cleanliness of food contact surfaces, including utensils, as evidenced by:
o A fried fish ball that was cooked during production on 2/28/07 was observed on the cooling line on 3/1/07 and 3/2/07;
o On 2/28/07, during a production run, encrusted dried product residue was observed on food contact surfaces of in-use processing equipment, including cooking and cooling equipment; o Wooden utensils that are used to handle fishery product, including cooked product, were observed to be inadequately cleaned.
o On 2/28/07 a worker, was observed using only water to clean one such wooden utensil.
3. Your firm did not adequately monitor the protection of food and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminates as required by 21 CFR 123.11(b)(5) with sufficient frequency to ensure control as evidenced by product residue and rust on pipes directly over exposed fishery product during cooking and cooling process and peeling paint on cooking line parts that are directly above and adjacent to food contact surface.
III. You must maintain sanitation control records, that, at a minimum, document monitoring and corrections 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, 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 cooked vacuum packaged refrigerated/frozen ready-to-eat fish balls and cooked vacuum packaged refrigerated/frozen ready-to-eat fish cakes. Specifically, sanitation control records were not maintained for the period of October 26, 2006 through February 27, 2007.
Your significant labeling violations were:
IV. Your Fried Fish Cake (7oz), Fish Ball (7oz), and Fri ed Fish Ball (6oz) products are misbranded under section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that these products are composed of two or more ingredients and their labels fail to declare the common or usual name of each ingredient as required by 21 CFR 101.4. Specifically, evidence collected during our inspection found that wheat gluten is used in the processing of all of your products; however, your labels fail to declare the wheat gluten ingredient in their ingredient statements.
V. Your Fried Fish Cake (7oz), Fish Ball (7oz), and Fried Fish Ball (6oz) products are also misbranded under section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels for these products fail to declare the presence of the major food allergen "wheat" as specified by section 403(w)(1). Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines as "major food allergens" milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:
o The word "Contains," followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients (section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]), or
o The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) (section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)J).
Specifically, these products contain the allergen wheat gluten, however, your product label fails to declare the presence of this allergen. The specific labeling requirements of section 403(w) can be accessed on our website at www.cfsan.fda.gov/~dms/alrgact.html. Further guidance and information on food allergens can be accessed on our website at http://www.cfsan.fda.gov/~dms/wh-alrgy.html
VI. Your Fried Fish Cake (7oz), Fish Ball (7oz), and Fried Fish Ball (6oz) products are also misbranded under section 403(q) of the Act [21 U.S.C. § 343(q)] because they fail to declare trans fat in their Nutrition Facts panels [21 CFR 101.9(c)(2)(ii)]. Regulations requiring the declaration of trans fat went into effect on January 1, 2006 [see 21 CFR 101.9(c)(2)(ii); 68 FR 41433]. You should review all of your product labels to ensure they comply with these regulations. For additional information on trans fat labeling, go to http://www.cfsan.fda.gov/~dms/lab-cat.html#transfat.
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, labeling, 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.
In addition to the aforesaid deviations, evidence collected during our inspection found that fresh Whiting was the only fish being used to manufacture your fish ball and fish cake products at that time; however, your Fried Fish Cake (7oz), Fish Ball (7oz), and Fried Fish Ball (6oz) product labels all declared "Fresh Fish Whiting" and "seatrout" in their ingredient statements. Furthermore, your labels declare the ingredient peanut oil, but during the inspection you stated that your firm uses only soybean oil (not peanut oil) in the processing of all of your products. As previously stated, you must declare the common or usual name of each ingredient in ingredient statement as specified under 21 CFR 101.4.
Also, we note that your labels include information in foreign characters but fail to provide all required label information in the foreign language [21 CFR 101.15(c)(2)].
Finally, all information required to appear on your product label's information panel pursuant to 21 CFR Part 101 must appear in one place, without intervening material [21 CFR 101.2(e). The use of the term "fresh" to describe the fish ingredient in the ingredient statement, such as on the label of your Fried Fish Cake (7oz), Fish Ball (7oz), and Fried Fish Ball (6oz) products, is not part of the usual or common name of the ingredient and is, therefore, intervening.
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), the Current Good Manufacturing Practice regulation (21 CFR Part 110), and the food labeling regulations (21 CFR Part 101). 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 U.S. Food and Drug Administration, New York District, 158-15 Liberty Avenue, Jamaica, New York 11433, Attention: Anna Alexander, Compliance Officer, HFR-NE 140.
If you have questions regarding any issues in this letter, please contact Ms. Alexander at (718) 340-7000 ext. 5683.
Otto D. Vitillo