WARNING LETTER
Cali Rice Valley Inc.
MARCS-CMS 605184 —
May 29, 2020
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Cuong T. Do
Recipient Title
General Manager & Co-Owner
Cali Rice Valley Inc.
1950 Innes Ave, Suite 5
San Francisco
,
CA
94124
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
WL 605184
5/29/2020
Dear Mr. Do:
The United States Food and Drug Administration (FDA) inspected your seafood processing and noodle manufacturing facility, located at 1950 Innes Ave, Suites 4-7 and 9-13, San Francisco, CA, on November 19, 20, 25, December 3, 10, 11, 31, 2019, and January 6, 14, and 21, 2020. During our inspection of your facility, FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Based on FDA’s inspectional findings, we have determined that the ready-to-eat (RTE) rice noodles and wheat noodle products manufactured in your facility are 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)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links on FDA's website at
http://www.fda.gov.
We also found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, [Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 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 Act [21 U.S.C. § 342(a)(4)]. Accordingly, your RTE Rice Valley brand Shrimp Rice Rolls are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act, the seafood HACCP regulation, the Fish and Fisheries Products Hazards & Controls Guidance and FDA regulations through links on FDA’s website at
http://www.fda.gov.
In addition, 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 color additives which are unsafe within the meaning of section 721(a) of the Act [21 U.S.C. §379e(a)].
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).
This letter is not intended to be an all-inclusive list of the violations that may exist at your facility or about your products. It also does not indicate that FDA has conducted an all-inclusive review of all the products you manufacture and/or distribute. It is your responsibility to ensure the products you manufacture and/or distribute are following all applicable statutes and regulations, including the Act and applicable FDA regulations. You should take prompt action to correct all the violations noted in this letter and establish and implement procedures that will prevent the recurrence of these violations and the occurrence of other violations. Failure to correct and prevent these violations, or similar ones, may result in FDA taking regulatory action, including, without limitation, seizure or injunction.
Within fifteen (15) business days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)].
For a domestic facility, FDA will assess and collect fees for reinspection-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 to 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 reinspection related costs.
Please send your written response to the attention of:
Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502
Refer to Unique Identification Number #605184 when replying.
If you have questions regarding this letter, please contact Elodie Tong-Lin, Compliance Officer, at elodie.tong-lin@fda.hhs.gov or
510-337-6870
.
Sincerely,
/S/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations –West Division 5
Content current as of:
06/16/2020
Regulated Product(s)
Food & Beverages