- As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent.Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
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- Cali Rice Valley Inc.
- San Francisco
A noodle and seafood company in San Francisco is on notice from the FDA for serious violation of the food code, including Listeria in its factory and multiple sanitary problems including employees pickup food from the floor and sending it on for packaging.
In a May 29 letter to Cuong T. Do, general manager and co-owner of Cali Rice Valley Inc., federal officials cited problems discovered during inspections from November 2019 through January this year. Inspectors from the Food and Drug Administration reported multiple violations of federal law, including watching while an employee sneezed into his hand and then continued to work with ready-to-eat (RTE) food without cleaning hands or gloves.
Other significant violations involved failure to have required food safety plans and accompanying documentation that the plans are being followed. The company had failed to resolve other problems such as condensation dripping from dirty pipes on to food.
Many environmental problems were documented by inspectors, including test results for pathogens.
“On Dec. 11, 2019, FDA performed environmental sampling in the Wheat Noodle Manufacturing Room and Rice Noodle Manufacturing Room within your facility. Seven locations were found positive for Listeria innocua — including the food contact surface of the conveyor belt on Line (redacted), along with non-food contact surfaces such as floors and drains within your processing environment,” according to the FDA warning letter.
“Findings of Listeria innocua within your processing environment can be an indicator of inadequate sanitation and of conditions that support the growth of Listeria monocytogenes, a human pathogen.
“Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your products described below to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].
To date we have not received a response to the FDA Form-483.”
Your significant violations are as follows:
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
1. You did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for RTE rice noodles and wheat noodles manufactured or processed at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR § 117.130(a). Specifically,
a. You did not identify bacterial growth and/or toxin formation of Bacillus cereus due to lack of time/temperature control as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control. Your firm’s RTE finished product rice noodles are not refrigerated and are not labeled for refrigeration. During the inspection, Vietnamese Rice Sheet was stored at an ambient temperature of approximately 71°F for over four hours before delivery in an ambient truck for an additional three to four hours. An FDA sample of Vietnamese Rice Sheet was analyzed, with water activity exceeding 0.99 and pH ranging from 5.71 to 6.19.
b. You did not identify environmental pathogens, such as Listeria monocytogenes, as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control. Your firm’s RTE rice noodles and wheat noodles are exposed to the environment after (b)(4) and then handled by employees prior to packaging. The packaged noodles do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogens or control by the supply chain or downstream customer) that would significantly minimize the pathogens.
We note that you are not performing environmental monitoring to evaluate the effectiveness of your sanitation practices regarding employee practices and cleanliness of food contact surfaces. On December 11, 2019, FDA performed environmental sampling in the Wheat Noodle Manufacturing Room and Rice Noodle Manufacturing Room within your facility. Seven (7) locations were found positive for Listeria innocua (including the food contact surface of the conveyor belt on Line (b)(4), along with non‐food contact surfaces such as floors and drains within your processing environment).
Findings of Listeria innocua within your processing environment can be an indicator of inadequate sanitation and of conditions that support the growth of Listeria monocytogenes, a human pathogen.
c. You did not identify and evaluate undeclared allergens as a known or reasonably foreseeable hazard to determine whether they are a hazard requiring a preventive control. Your facility manufactures rice noodles and wheat noodles which contain allergens.
d. You did not identify and evaluate undeclared color additives as a known or reasonably foreseeable hazard to determine whether they are a hazard requiring a preventive control. Your facility manufactures wheat noodles which contain color additives.
e. You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they are a hazard requiring a preventive control. Your facility manufactures noodles from rice and wheat, ingredients that have been associated with mycotoxins.
2. You did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the RTE rice noodles and wheat noodles manufactured, processed, packed, or held by your
facility will not be adulterated under Section 402 of the Act or misbranded under section 403(w) of the Act [21 CFR § 117.135(a)(1)]. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply‐chain controls, and a recall plan (see 21 CFR § 117.135). Preventive controls are subject to preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system (see 21 CFR § 117.140).
3. You did not prepare, or have prepared, and did not implement a food safety plan for the RTE rice noodles and wheat noodles manufactured in your facility, such as RTE rice noodles and wheat noodles, as required by 21 CFR § 117.126. A food safety plan must include the following:
(1) The written hazard analysis, as required by § 117.130(a)(2);
(2) The written preventive controls, as required by § 117.135(b);
(3) The written supply‐chain program, as required by subpart G;
(4) The written recall plan, as required by § 117.139(a);
(5) The written procedures for monitoring the implementation of the preventive controls, as required by § 117.145(a);
(6) The written corrective action procedures, as required by § 117.150(a)(1); and
(7) The written verification procedures, as required by § 117.165(b).
Current Good Manufacturing Practice (Subpart B):
1. Your plant was not constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food‐contact surfaces, or food‐packaging materials, as required by 21 CFR § 117.20(b)(4). For example, during the inspection, condensation from the lights above the (b)(4) and (b)(4) lines was observed to be dripping directly onto RTE Vietnamese rice sheets before the rice sheets were packaged.
2. You did not take reasonable measures and precautions to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR § 117.10(b). Our investigators observed the following conditions which can result in the recontamination of the RTE food with environmental pathogens:
• Employees sneezing into their bare or gloved hands before handling RTE wheat noodles after the (b)(4) step
• Employees smoking cigarettes outside the facility before returning to work and directly touching and packaging RTE wheat noodles without washing their hands
• Employees touching their noses and mouths before directly touching RTE wheat noodles
• An employee dropping handfuls of RTE Vietnamese Rice Sheets onto the wet floor at the (b)(4) line, then picking them up off the floor and passing them to the packaging line
3. You failed to exclude pests from your food plant to protect against contamination of food, as required by 21 CFR 117.35(c). Specifically, our investigators observed the following:
• An apparent live rodent in your RTE manufacturing room (b)(4)
• Rodent excreta pellets inside your cooler (confirmed by FDA sample INV1110822)
• A bird fly into your warehouse next to your cooler and fly into your RTE manufacturing room (b)(4)
• Birds actively dropping apparent excreta on bags of flour and rice
• Gaps in wall and doors, including a 2” gap at the corner of entrance door to Suite (b)(4); a 5” gap adjacent to the entrance door to Suite (b)(4); and a gap on the entire bottom side of the door to Suite (b)(4)
4. You did not clean and sanitize utensils and equipment in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(a). Specifically, employees were observed using (b)(4) hoses to rinse the ground, which resulted in water and mist landing on previously cleaned food processing equipment, including the (b)(4) and (b)(4) lines.
Seafood HACCP
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 Ready-to-Eat Shrimp Rice Rolls to control the food safety hazards of pathogens, undeclared allergens, and intolerance causing substances.
Your shrimp rice roll products are RTE without further cooking by the consumer and contain allergenic ingredients, such as wheat (wheat starch), crustacean shellfish (dried shrimp), and food intolerance causing ingredients such as sulfiting agents (sodium acid sulfate). Therefore, your firm must have and implement a HACCP plan that adequately controls the food safety hazards of pathogenic bacteria survival through cooking or pasteurization, pathogenic bacterial growth and toxin formation as a result of time and temperature abuse, undeclared allergens, and food intolerance causing substances. For more information on developing a HACCP plan, FDA recommends you review the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition (the Hazards Guide).
Adulteration due to unsafe color additives
Your Instant Noodles and Ready Cooked Noodles products are also adulterated under section 402(c) of the Act) [21 U.S.C. § 342(c)] because they contain a color additive which is unsafe within the meaning of section 721(a) of the FD&C Act [21 U.S.C. §379e(a)] because the color additive is not used in conformity with its conditions for use. FD&C Yellow No. 5 is specifically required to be declared on food product labels (see 21 CFR 74.705(d)(2)). Tartrazine (another name for FD&C Yellow No. 5) was found in the “Instant Noodles” product and used as an ingredient in both products but was not declared on the product labels.
Misbranding Violations
Review of your finished product labels reveals that they are misbranded for the following reasons:
1. Your Buttery Chocolate Fullbread, Medeleines, and Instant Noodle products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)]. The Buttery Chocolate Fullbread and Medeleines finished product labels list butter but fail to declare the major food allergen “milk” as required by section 403(w)(1) of the Act. The Medeleines label also lists cake flour but fails to list the major allergen wheat. The packages of Instant Noodles produced during the inspection failed to bear a label that listed the major allergen wheat. The Contains statement on the Ready Cooked Noodles fails to declare eggs. Please be advised that if you choose to use a “Contains” statement it must include all major food allergens in the food.
2. Your Instant Noodles and Ready Cooked Noodles products are misbranded under section 403(k) of the FD&C Act because the products contain artificial coloring and fail to bear labeling stating that fact. FD&C Yellow No. 5 and FD&C Yellow No. 6 are not declared on the product labels by their listed names or appropriate abbreviations as required under 21 CFR 101.22(k)(1).
3. Your Buttery Chocolate Fullbread, Chow Fun, and Medeleines products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the labels fail to declare the net quantity of contents in accordance with 21 CFR 101.7. For example:
a. Your Medeleines label fails to list the net quantity of contents, 21 CFR 101.7(a);
b. Your Buttery Chocolate Fullbread and Chow Fun labels fail to list the net weight in pounds (in addition to ounces), 21 CFR 101.7(j).
4. Your Instant Noodles, Chinese Style Noodles, and Buttery Chocolate Fullbread products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4:
a. Your Instant Noodles and Chinese Style Noodles product labels fail to bear a statement of ingredients, 21 CFR 101.4(a)(1);
b. Your Buttery Chocolate Fullbread label fails to list the chocolate ingredient and its sub ingredients and lists the ingredient “cake shortening” which is not the common or usual name of a food ingredient, 21 CFR 101.4(b)(14). The label also lists “dough conditioner” without specifying the specific dough conditioner(s) used, 21 CFR 101.4(b)(18).
5. Your Buttery Chocolate Fullbread, Medeleines, Vietnamese Rice Sheet, Ready Cooked Noodles, Instant Noodles, Chinese Style Noodles, and Chow Fun products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because their labels fail to comply with 21 CFR 101.9:
a. The Buttery Chocolate Fullbread, Medeleines, Instant Noodles, and Chinese Style Noodles fail to bear nutrition information, 21 CFR 101.9(a);
b. The Vietnamese Rice Sheet Nutrition Facts label (NFL) declares a percent daily value for trans fat which is not in accordance with 21 CFR 101.9(c)(2)(ii), and fails to declare calories from fat, 21 CFR 101.9(c)(1)(ii). This NFL also has formatting issues such as improper bolding and misspelling.
c. The Ready Cooked Noodles Nutrition Facts label fails to list a serving size that is based on the 140-gram RACC for pastas, plain, prepared. As a result, all nutrient amounts are incorrect. 21 CFR 101.9(b) and 21 CFR 101.12(b).
d. The Ready Cooked Noodles Nutrition Facts label’s format does not comply with the requirements in 21 CFR 101.9. For example, the Nutrition Facts label is not set off in a box in accordance with 21 CFR 101.9(d)(1)(i); the ingredients list is not permitted to be within the NFL; the heading “Nutrition Facts” does not meet the requirements in 21 CFR 101.9(d)(2) which requires it to be in type size larger than all other print and set the full width of the panel; and the nutrition label declares a percent daily value for trans fat which is not in accordance with 21 CFR 101.9(c)(2)(ii).
e. The Chow Fun label’s NFL fails to declare calories from fat, 21 CFR 101.9(c)(1)(ii); declares a percent daily values for trans fat and sugars which is not in accordance with 21 CFR 101.9(c)(2)(ii) and 21 CFR 101.9(c)(6)(ii), respectively; and the footnote required by 21 CFR 101.9(d)(9) or 21 CFR 101.9(j)(13)(ii) is missing. This NFL also has formatting issues such as improper bolding and misspelling.
We also note that for the Vietnamese Rice Sheet and Chow Fun nutrition labels, it appears the number of servings was rounded (200g serving size*2.5 servings per container=500g, vs. Net Wt. of 454 g). Rounding should be indicated by the use of the term about (e.g., about 2 servings, about 3.5 servings).
As you may already know, FDA finalized new requirements for nutrition labeling on May 27, 2016. The new Nutrition Facts label includes updates to the required nutrient declarations and formatting requirements. Manufacturers must revise labels to meet the new requirements. For more information on the new requirements, please see https://www.fda.gov/food/food-labeling-nutrition/changes-nutrition-facts-label.
6. Your Buttery Chocolate Fullbread, Vietnamese Rice Sheet, Ready Cooked Noodles, Instant Noodles, and Chinese Style Noodles products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product labels contain information in foreign languages, but do not repeat all the required information in all languages as required by 21 CFR 101.15(c)(2). The statement of identity, ingredients, net quantity of contents, Nutrition Facts, name and address of the responsible firm, and allergen information must be on the labels in all languages used on the labels.
7. Your Buttery Chocolate Fullbread, Medeleines, and Chow Fun products are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels do not bear appropriate statements of identity in accordance with 21 CFR 101.3.
In addition, please be advised that the statements of identity shall be on the label in lines generally parallel to the base on which the product rests as it is designed to be displayed, 21 CFR 101.3(d).