WARNING LETTER
California Bread Co.
MARCS-CMS 674283 —
April 25, 2024
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Steve S. Shorees, CEO
Recipient Title
Mr. Rene A. Garcia, President
California Bread Co.
681 Anita St, Ste 106
Chula Vista
,
CA
91911
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
April 25, 2024
Dear Mr. Shorees and Mr. Garcia:
The United States Food and Drug Administration (FDA) inspected your manufacturing facility, located at 681 Anita St, Ste 106, Chula Vista, CA 91911, from October 24 through November 28, 2023. The inspection revealed significant 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 you did not follow the requirements of the CGMP & PC rule. The 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.
In addition, your Egg Bread product is also adulterated under section 402(c) of the Act [21 U.S.C. § 342(c)] because it contains a color additive which is 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].
At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations. We received your response describing corrective actions to the FDA-483 on December 13, 2023, with additional documentation received on December 20 and 21, 2023. After reviewing the inspectional findings and your responses, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. Your responses are addressed below as necessary.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR 117 Subpart C):
1. Your written allergen preventive control did not include procedures, practices, and processes employed for labeling to ensure that all food allergens required to be stated are included on the label for your RTE bread products, as required by 21 CFR 117.135(c)(2)(ii).
Specifically, your hazard analysis for your various bread products (part of your HACCP Plan dated November 2, 2023) identified allergens as a significant hazard requiring a Critical Control Point (CCP) at the packaging/labeling step. However, your Allergens Management Program did not specifically identify the milk allergen in your sweet whey ingredient. You did not declare the milk allergen on your label for La Torta (Telera) bread products, lot # TAN NOV15, on November 2, 2023. You initiated a voluntary recall the following day covering La Torta (Telera) bread products manufactured back through October 24, 2023.
Your December 13, 2023 response states that you are in the process of ordering new La Torta Bread printed bags, and that you are temporarily placing a corrected printed label on top of old printed bags or clear bags. Your December 21, 2023 response includes a revised process control at the “Labeling and Print bag” step which addresses allergen declaration accuracy. It also addresses application of temporary or sticker labels (i.e., ensuring that correct labels are placed on old/printed or clear bags), but it does not appear to address use of printed bags in production (i.e., ensuring that correct preprinted bags are used while packaging finished product). Furthermore, you have not provided supporting documentation demonstrating you have implemented the finished product label check for allergen declarations. In your response to this letter, you should provide your revised written preventive control procedures and completed allergen labeling monitoring records for at least five consecutive days of production.
2. You did not identify and evaluate all known or reasonably foreseeable hazards to determine whether there are hazards requiring a preventive control for your RTE bread products, as required by 21 CFR 117.130(a)(1).
Specifically, your hazard analysis for your various bread products did not identify and evaluate the hazard of undeclared color additives, to determine whether it requires a preventive control. Your facility manufactures bread products (including Egg Bread) containing color additives (including FD&C Yellow #5). FD&C Yellow #5 is known to cause adverse reactions in sensitive individuals, including bronchial asthma in asthmatic individuals. A knowledgeable person manufacturing/processing food in your circumstances would identify undeclared FD&C Yellow #5 as a hazard requiring a preventive control. Preventive controls include procedures, practices, and processes necessary to ensure that food manufactured processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) (see 21 CFR 117.135(a)(1) and 21 CFR 117.135(c)(6)), such as during receipt of labels and during packaging/labeling operations, to ensure FD&C Yellow #5 is declared for products containing this color additive.
You did not have controls in place, as evidenced by your manufacturing and distributing Egg Bread, lot # TAN NOV15, on November 2, 2023, with labels that did not declare the presence of FD&C Yellow #5.
Your December 13, 2023 response states that Egg Bread bags are currently being labeled with a revised/corrected label, placed on top of the printed bags. You are awaiting your bag supplier’s new plates to begin printing corrected new Egg Bread Bags. Your December 21, 2023 response includes a process control for undeclared sub-ingredients in Egg Bread. Your critical limit requires that egg shade containing Yellow #5 and Yellow #6 be specified in the labels or printed bags. However, your critical limit does not include ensuring that Egg Bread labels or bags are used in production while packaging the Egg Bread. Furthermore, you have not provided supporting documentation demonstrating you have implemented the finished product label check for color additive declarations. In your response to this letter, you should provide your revised written procedures for undeclared color additives and completed labeling monitoring records for at least five consecutive days of production.
3. You did not implement your preventive controls procedures to significantly minimize or prevent contamination with the hazard of environmental pathogens in your RTE bread products, as required by 21 CFR 117.135(a)(1).
Specifically, your hazard analysis for your various bread products, including RTE La Torta Bread (Telera Bread), identified the hazard of non-spore forming pathogens such as E. coli, Salmonella, and Listeria as requiring a preventive control at the “
(b)(4)
” step. Also, your written Sanitation Standard Operating Procedure (SSOP) required that you “[o]bserve equipment for missing parts or parts/surfaces that are worn to the extent that debris will accumulate and cause product contamination. When the preventive maintenance technician is involved, he must replace or repair parts/surfaces per request or as needed, and document what was done in the work order.” However, during production of your RTE La Torta Bread (Telera Bread), lot # TAN NOV15, on November 2, 2023, FDA investigators observed that the food-contact conveyor belt on the LeMatic slicer (
(b)(4)
) was discolored, contained frayed edges, and had an unsmooth metal lace. Your Pre-Operational / Post-Operational Daily Inspection Sheet for November 2, 2o23, found that the packaging areas were “in good order, clean & sanitized.”
Your December 13, 2023 response states that you have
(b)(4)
and that your Quality Assurance personnel oversees monitoring for repairs and corrective actions on a
(b)(4)
basis. Your corrective actions will be verified during the next FDA inspection.
Color Additive Labeling
Your Egg Bread products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the products bear or contain a color additive which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379e(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive listing regulation. Specifically, the listing regulation for FD&C Yellow No. 5 requires that this certified color additive be listed as “FD&C Yellow No. 5” in the ingredient list on the labels of foods for human use that contain FD&C Yellow No. 5 [21 CFR 74.705(d)(2)]. Your Egg Bread product is manufactured with
(b)(4)
Egg Shade which contains FD&C Yellow No. 5; however, the label for this product fails to declare FD&C Yellow No. 5 in the ingredient statement.
Misbranding
1. Your La Torta Bread (72 oz.), Telera (32 oz. and 61 oz.), and Egg Bread (24 oz. and 32 oz.) products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients and each ingredient is not declared on the label and the labels fail to declare the ingredients by their common or usual names, as required by 21 CFR 101.4. Specifically:
a. The La Torta Bread product label does not list the ingredients in descending order of predominance by weight, as required by 21 CFR 101.4(a)(1). The label lists yeast after gluten, but your product formula indicates the amount of yeast used to manufacture the product is higher than the amount of gluten.
b. The La Torta Bread and Egg Bread ingredient lists declare the terms “Tempest,” “Viva Fresco Prime 150,” “softener,” “Lovibond red color,” and “Lovibond yellow color,” and the Telera label includes the terms “Tempest” and “softener,” none of which are appropriate common or usual names of ingredients, as required by 21 CFR 101.4(a). The Lovibond is a scale of color measurement and not an ingredient. “Tempest” and “Viva Fresco Prime 150” appear to be brand names. “Softener” appears to be a description of the function of an ingredient; however, it is not a term provided for in 21 CFR 101.4.
c. The term “fresh” on the La Torta Bread, Telera, and Egg Bread ingredient lists is not part of the common or usual name of yeast.
d. The term “Egg Shade Powder” on the Egg Bread product label is not an appropriate declaration for colors.
e. The Telera label declares “Salad Oil (soybean oil)” which is not declared in accordance with 21 CFR 101.4(b)(14).
f. The Egg Bread product label lists “Egg Shade Powder (Yellow#5, Yellow#6);” this is not an appropriate declaration for colors.
2. Your La Torta Bread (72 oz.), Telera (32 oz. and 61 oz.), and Egg Bread (24 oz. and 32 oz.) products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition information (e.g., Nutrition Facts label) does not comply with the requirements in 21 CFR 101.9. For example:
a. The nutrients, including the vitamins and minerals, declared in the Nutrition Facts label (NFL) are not in accordance with 21 CFR 101.9(c), and the format is not in accordance with 21 CFR 101.9(d).
b. Your pre-printed bread bags for both La Torta Bread and Egg Bread bear the nutrient content claims, “Cholesterol Free” and “No Trans Fat,” but the NFL does not include declarations for polyunsaturated fat and monounsaturated fat as required by 21 CFR 101.9(c)(2)(iii). Under 21 CFR 101.9(c)(2)(ii) and (iv), mono- and polyunsaturated fats must be declared on the NFL if claims about fatty acids or cholesterol are made on the label or in the labeling of a food other than one that meets the criteria in 21 CFR 101.62(b)(1) for a “fat free” claim.
c. The Egg Bread label does not declare Added Sugars in accordance with 21 CFR 101.9(c)(6) in that the label declares zero grams of added sugar, but light brown sugar is listed as the third most prominent ingredient.
d. The La Torta Bread product label contains a footnote not provided for under 21 CFR 101.9(d)(9).
3. Your Telera (32 oz. and 61 oz.) product is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product label does not contain an appropriate statement of identity, as required in 21 CFR 101.3(b). “Telera” is a Spanish term and is not an appropriate common or usual name.
4. Your La Torta Bread (72 oz.) and Telera (32 oz. and 61 oz.) products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343(f)] because the product labels provide information in two languages but do not repeat all required information in both languages. For example, both labels include foreign terms in the statement of identities; however, all required labeling is not also provided in the foreign language, as required by 21 CFR 101.15(c)(2).
5. Your Egg Bread (24 oz. and 32 oz.) product is misbranded within the meaning of section 403(g) of the Act [21 U.S.C. 343(g)]. The product appears to be represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401, but it does not appear to conform to such definition and standard in accordance with 21 CFR 136.110. Specifically, egg bread is subject to the standard of identity in 21 CFR 136.110 which requires, among other things, that the food shall contain not less than 2.56 percent of whole egg solids [21 CFR 136.110(e)(2)]; however, this product fails to contain egg as an ingredient.
This letter is not intended to be an all-inclusive list of the violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure or injunction.
In addition to the above violations, we offer the following comments:
The review of your firm’s product labels was limited to the products and sizes listed above. However, you should conduct a review of all your product labels and make appropriate corrections across all products and product sizes.
We note that the Telera, La Torta Bread, and Egg Bread products declare “soybean” in a “Food Allergy Contains” statement. If this statement is meant to be a “Contains” statement as provided for under section 403(w) of the Act, then the words “Food Allergy” need to be removed. Additionally, if the ingredient “soybean oil” is the only soy ingredient, and if it is highly refined soybean oil, then is it is not a major food allergen and it should not be declared in the “Contains” statement. You should review your product formulations to ensure all major food allergens and ingredients are declared appropriately.
As noted above, all the product labels bear the claim “No Trans Fat.” However, FDA has not authorized any nutrient content claims for trans fat, such as “trans fat free,” “no trans fat,” or “zero trans fat.” Under section 403(r)(1)(A) of the Act, a nutrient content claim in food labeling must be made in accordance with a regulation authorizing the use of the claim for the food bearing such a claim not to be misbranded. Although FDA has not defined the term “No Trans Fat” by regulation, we announced in the Federal Register dated July 11, 2003 (68 FR 41507 at 41509) that we would likely consider exercising enforcement discretion for a trans-fat nutrient content claim that is demonstrably true, balanced, adequately substantiated, and not misleading. We point out that, 21 CFR 101.13(i)(3) permits statements about the amount or percentage of a nutrient if the statement does not in any way implicitly characterize the level of the nutrient in the food, and it is not false or misleading in any respect (e.g., "0 g trans fat”).
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct any 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 actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1201 Harbor Bay Pkwy
Alameda, CA 94502
Refer to Unique Identification Number
674283
when replying.
If you would prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification Number in the title of the e-mail message.
If you have any questions regarding this letter, please contact Elodie X. Tong-Lin, Compliance Officer, at Elodie.Tong-Lin@fda.hhs.gov.
Sincerely,
/S/
Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations – West Division 5
Content current as of:
05/14/2024
Regulated Product(s)
Food & Beverages