WARNING LETTER
NRS Enterprises, Inc. d/b/a Sunflour Bakery
MARCS-CMS 681329 —
August 13, 2024
Delivery Method:
Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Rolf W. Bender
Recipient Title
Owner/CEO
NRS Enterprises, Inc. d/b/a Sunflour Bakery
2950 Grace Lane
Costa Mesa
,
CA
92626
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
August 13, 2024
WL 681329
Dear Mr. Bender:
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility, located at 2950 Grace Lane, Costa Mesa, CA, on February 15, 2024, to March 06, 2024. Your firm manufactures a variety of ready-to-eat (RTE) bakery products including, but not limited to breads, coffee cakes, and pies. During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at your firm. During the inspection your firm initiated a recall of three products due to undeclared allergens (soy and walnuts) and undeclared Yellow #5.
Based on FDA’s inspectional findings, we have determined that the RTE bakery 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)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or 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)]. Furthermore, we have reviewed your product labels that were collected during the inspection and found significant violations of the food labeling regulations, 21 CFR Part 101. These violations cause your product(s) to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343], as discussed below.
You may find the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov/.
On March 27, 2024, FDA received your written response describing corrective actions taken and planned by your firm. After reviewing the inspectional findings and your firm’s response, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We also address your response below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. You did not prepare, or have prepared, and implement a food safety plan, as required by 21 CFR § 117.126(a)(1). The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs), as required by 21 CFR § 117.126(a)(2). Your food safety plan must include the following:
1. The written hazard analysis, as required by 21 CFR § 117.130(a)(2);
2. The written preventive controls, as required by 21 CFR § 117.135(b);
3. The written supply-chain program, as required by Subpart G;
4. The written recall plan, as required by 21 CFR § 117.139(a);
5. The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
6. The written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
7. The written verification procedures, as required by 21 CFR § 117.165(b).
Your facility manufactures a variety of RTE bakery products, including but not limited to challah, sweet breads, wheat bread, and coffee cakes. However, you did not have a food safety plan with any of the required elements for any of the products manufactured by your facility. For example, you did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control (see 21 CFR § 117.130(a)). Also, 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 food 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 (see 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(c)). Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) 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). You must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system (see 21 CFR § 117.160). Specifically:
a. You did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control.
Your facility manufactures various bakery products that contain allergens (such as wheat, soy, eggs, tree nuts and sesame). Additionally, products containing different allergen profiles are processed on food-contact surfaces of shared equipment and utensils on the same production day. Therefore, allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact (including during storage, handling, and use) and for labeling to ensure that all food allergens required to be stated are included on the label (see 21 CFR § 117.135(c)(2)).
i. You do not have appropriate controls in place for undeclared allergens due to incorrect labeling, as evidenced by the following:
1. Your Hazelnut Coffee Cake, 16 oz, includes ingredients such as
(b)(4)
Wheat Flour and
(b)(4)
, that contain wheat. The filling contains both hazelnuts and walnuts, which are ground into a paste-like consistency where the walnuts and hazelnuts are no longer distinguishable. On February 16, 2024, and February 21, 2024, you applied one of two product labels, German Home Bakery brand or
(b)(4)
to the product; however, the
(b)(4)
branded label did not declare the wheat and walnut (tree nut) allergens.
2. Your Apple Coffee Cake, 16 oz., includes ingredients, such as
(b)(4)
Wheat Flour and
(b)(4)
, that contain wheat. You applied a German Home Bakery Apple Coffee Cake product label to the product which did not declare the wheat allergen.
3. Your Sunflour Bakery Banana Nut Sweet Bread includes soy flour as an ingredient; however, the product label applied to this product did not declare the soy ingredient in the ingredients lists nor does it identify the soy allergen in a “Contains” statement.
Your facility does not maintain any written records of label review.
ii. You do not have appropriate controls in place for allergen cross-contact, as evidenced by the following:
1. On February 15, 2024, our investigators observed RTE sesame challah and plain challah directly touching each other on the same baking sheet. Additionally, our investigators found stray sesame seeds on baking sheets containing only plain challah. You do not designate or identify specific racks for products with unlike-allergen profiles. You stated that all bakery products are cooled on the same racks. Furthermore, you stated the cooling racks are only washed
(b)(4)
.
2. On February 16, 2024, our investigators observed
(b)(4)
employees working on dough and filling for Marzipan (Almond) Coffee Cake and Hazelnut Coffee Cake. One employee transitioned from spreading the almond filling with his bare hands to spreading the hazelnut filling, one after the other, without washing his hands. The other
(b)(4)
employees responsible for scooping and rolling the dough also transitioned from handling the almond product to the hazelnut product without washing their hands. The Hazelnut Coffee Cake does not include almonds as an ingredient.
b. You did not identify and evaluate contamination with environmental pathogens, such as
Salmonella
, as a known or reasonably foreseeable hazard to determine whether it is hazard requiring a preventive control. Your facility manufactures RTE bakery products which are exposed to the environment after they exit the oven (such as while they are cooled, sliced, and packaged). The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. Therefore, contamination with environmental pathogens is a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control. Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling (see 21 CFR § 117.135(c)(3)). In addition, note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR § 117.165(a)(3)). Your facility does not conduct environmental monitoring.
i. You do not have appropriate controls in place for contamination with environmental pathogens, as evidenced by the following:
1. On February 16, 2024, our investigators observed your employee directly holding and rearranging RTE bread loaves coming out of the oven while wearing a pair of apparent fabric gloves. These gloves were re-used for every product and the employees wearing them also touch non-food-contact surfaces in between handling the RTE bread. The gloves are not washed or sanitized and are stored on top of a rusty/deteriorated wire frame rack and clipboard. The gloves appeared discolored/stained.
2. On February 16, 2024, and February 21, 2024, our investigators observed employees in the packaging area handling RTE bread loaves for cutting and bagging. We observed one employee simultaneously moving the cooling racks, preparing the packaging line, and grabbing and squeezing multiple RTE products with his bare hands on each rack to assess whether they were cooled enough for packaging. The employee continued to prepare the packaging line while handling various non-food-contact surfaces before returning to touch the RTE bread loaves again without washing and sanitizing his hands. Furthermore, these cooling racks were observed to have apparent buildup/residue on the food-contact surfaces, and you stated they were washed less than
(b)(4)
.
c. You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your facility manufactures RTE bakery products that contain wheat flour and tree nuts (e.g., walnuts and hazelnuts). These ingredients have been associated with mycotoxins. Mycotoxins are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in these ingredients. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR § 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR § 117.410). You do not have this program in place.
Your response received on March 27, 2024 provides corrective actions you have taken or plan to take including revision of German Home Bakery Hazelnut Coffee Cake, German Home Bakery Apple Coffee Cake, and Sunflour Bakery Banana Nut Sweet Bread finished product labels to identify all corresponding food allergens; applying sesame seeds to challah in a separate location; washing reusable gloves
(b)(4)
and replacing them
(b)(4)
; increasing the cleaning frequency to cooling racks to
(b)(4)
; requesting “mycotoxin certificates from [y]our suppliers”; and retraining employees in allergen handling and proper handwashing procedures. The revised finished product labels appear to identify each allergen included per product. However, you did not provide evidence to demonstrate implementation of your other corrective actions. Further, your response includes a statement that “All of the
(b)(4)
” have been destroyed.” However, it is not clear if you are referring to the product itself or the finished product labels.
Furthermore, your response does not indicate if you plan to conduct a hazard analysis for each product and develop and implement a food safety plan with all required elements.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
1. You did not clean your non-food-contact surfaces of equipment used in the operation of a food plant in a manner and as frequently as necessary to protect against contamination of food, food-contact surfaces and food packaging materials, as required per 21 CFR § 117.35(e). Specifically:
a. On February 15, 2024, apparent residue and buildup was observed on the stands of the
(b)(4)
and
(b)(4)
mixers, adjacent to food-contact surfaces. Further, on February 15, 2024, February 16, 2024, and February 21, 2024, apparent buildup and residue was observed on the interior and exteriors of
(b)(4)
mixers, including the mixing arm and interior walls of the mixing guards.
b. On February 15, 16, and 21 2024, apparent residue and buildup was observed on the exterior of ingredient holding containers/bins and push carts for holding baking sheets/trays. Your employees were observed handling the containers and lids, and other the unclean surfaces, and then coming into contact with raw ingredients and food-contact surfaces.
c. On March 4, 2024, RTE loaf breads held on the cooling carts were pushed through the hanging plastic curtains and stored adjacent to the curtains. The curtains appeared discolored and covered in dust/residue. The cart and the bread on the top of the cart contacted the curtains as they passed through. You stated the cleaning frequency of the curtains is about
(b)(4)
.
d. On February 16, 2024, and March 4, 2024, product residue/buildup was observed on the inner/outer surfaces of the bread slicer, adjacent and directly above the conveyor belt that transports RTE bread through the slicer.
In your written response, you promise to develop a cleaning program to include all equipment, including scales, mixers, bins, racks, and slicers. You estimate it would be completed by June 2024. However, to date, you have not provided an update regarding the status of your corrective actions.
2. You do not take effective measures to exclude pests from the manufacturing, processing, packing and holding areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR § 117.35(c). Specifically:
a. On February 15, 16, and 21, 2024, our investigators observed apparent flying insects around the multi-compartment sink, on the
(b)(4)
chemical dispenser, on a floor mop, and on the exterior wall of the
(b)(4)
. Our investigators also observed apparent flying insects on food-contact surfaces (i.e., dough worktable, mixer, ingredient storage bins, baking sheets), and on both in-process products and RTE products.
b. On February 15 and 16, 2024, and March 4, 2024, our investigators observed a total of seven apparent dead cockroaches in the holding areas; specifically, three adjacent to the freezer door, three adjacent to the cooler door, and one underneath the multi-compartment sink. On February 21, 2024, our investigators observed one apparent cockroach, that was on its back but still moving, to the left of the multi-compartment sink. On February 21, 2024, our investigators also observed one apparent live small cockroach underneath the multi-compartment sink.
In your response, you explain you will work closer with your pest control company to eliminate pests. In addition, you state that you have fixed a leak in the sink which will keep the area dry and eliminate the fruit flies in that area. Further, you state you may add screens to floor drains to prevent cockroaches from entering. However, you should consult with your pest control company to develop and implement an integrated pest control program as floor drain screens are typically used to prevent larger items from clogging the drain and are not an effective pest control solution for cockroach nymphs who can easily climb through the screens. Lastly, you promise to
(b)(4)
clean equipment and remove obsolete equipment. We are not able to evaluate corrective actions as you did not provide documentation such as pest control reports and photographs to show implementation of your plan.
3. Your equipment and utensils used in manufacturing, processing, packing or holding food are not designed and of such material and workmanship as to be adequately cleanable, and are not adequately maintained to protect against allergen cross-contact and contamination, as required per 21 CFR § 117.40(a)(1).
Specifically, your
(b)(4)
dough rollers (metal-mesh and fabric) are not constructed of materials that are easily cleanable. Discoloration and deterioration were observed on the felt dough roller where the in-process dough is rolled and compressed by the felt material. You stated the felt is cleaned only by scraping and dusting because it cannot be washed. The conveyor belt on the metal-mesh dough roller was cracked and missing sections/edges, resulting in uneven/split surfaces. You stated that this conveyor belt is also only cleaned by scraping and dusting.
In your response, you promise to replace the “metal-mesh” dough roller belt with one that may be wet cleaned by May 2024. You also promise to replace the felt belt and to research if there is an alternative that will allow for wet cleaning. We acknowledge this appears to be an appropriate corrective action plan; however, you do not provide documentation to support the timeframe for the “metal-mesh” dough roller belt and do not provide evidence to demonstrate the felt belt has been replaced.
Furthermore, in your written response, you promise to retrain your employees “not to store anything directly on the floor” and “not to store finished products right next to ingredients.” Further, you acknowledge that products that fall on the floor needed to be discarded. However, we are not able to assess your corrective action as you did not provide evidence of employee training or provide a date when it will be provided and did not provide evidence to demonstrate you corrected your storage practices.
Misbranding Violations
Your Marzipan Coffee Cake, Poppy Coffee Cake, Raspberry Coffee Cake, Apple Coffee Cake, Cherry Coffee Cake, Hazel Nut Coffee Cake, and Banana Nut Sweet Bread 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) is not provided in accordance with the requirements in 21 CFR 101.9.
Your Marzipan Coffee Cake, Poppy Coffee Cake, Raspberry Coffee Cake, Apple Coffee Cake, Cherry Coffee Cake, and Hazel Nut Coffee Cake 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(b)(2). Specifically:
• Your coffee cake dough was formulated with
(b)(4)
; however, its ingredients were not declared on the label. The sub ingredients of the “
(b)(4)
” contain the following ingredients: wheat flour,
(b)(4)
.
• “Lemon Juice Flavor” is declared in the labels collected during the inspection for the Hazelnut Coffee Cake, Marzipan Coffee Cake, Poppy Coffee Cake, Raspberry Coffee Cake, and Cherry Coffee Cake; however, no flavor ingredients are declared in the revised labels for Hazelnut Coffee Cake, Marzipan Coffee Cake, and Poppy Coffee Cake. “Flavor” is declared on the revised Raspberry Coffee Cake label. If the lemon flavor is a natural flavor, it may be declared as “flavor.”
Your Banana Nut Sweet Bread product is also misbranded within the meaning of section 403(i)(2) of the Act since it is also fabricated from two or more ingredients, and each ingredient is not declared on the label, as required by 21 CFR § 101.4(b)(2). Specifically, the product was formulated with
(b)(4)
; however, all its ingredients were not declared on the label. We also question if the Banana Puree is a multi-ingredient component, and the sub-ingredients are not declared on the label. The sub ingredients for the “
(b)(4)
” contain the following ingredients: Sugar, Unbleached Wheat Flour,
(b)(4)
.
• The revised label for the Banana Nut Sweet Bread product declares “baking powder”. Baking powder is a multicomponent ingredient for which the sub ingredients must be declared in accordance with 21 CFR 101.4(b)(2).
• You provided a revised Banana Nut Sweet Bread label. However, the revised label does not list the ingredients in descending order of predominance by weight, as required by 21 CFR 101.4(a)(1). Sugar is listed as the fifth ingredient on your label; however, it is listed first on the
(b)(4)
label.
Furthermore, the revised Hazelnut Coffee Cake product label declares the ingredient “evaporated cane juice.” In our Guidance for Industry: Ingredients Declared as Evaporated Cane Juice (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-ingredients-declared-evaporated-cane-juice), we advised the regulated industry of our view that the term “evaporated cane juice” is not the common or usual name of any type of sweetener and that this ingredient should instead be declared on food labels as “sugar,” preceded by one or more truthful, non-misleading descriptors if the manufacturer so chooses (e.g., “cane sugar”).
Your Raspberry Coffee Cake product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] because the label fails to bear a net quantity of contents statement as required by 21 CFR 101.7. And note that the net quantity of contents declaration on the revised Cherry Coffee Cake and Apple Coffee Cake product labels is not appearing as a distinct item on the principal display panel as required by 21 CFR 101.7(f).
Your Poppy Coffee Cake, Raspberry Coffee Cake, Apple Coffee Cake, and Cherry Coffee Cake products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)] because the revised labels declare chemical preservatives such as “sodium benzoate” and “potassium sorbate” but fails to bear labeling stating that fact in accordance with 21 CFR 101.22(j). Specifically, a food to which a chemical preservative(s) is added must bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention.” Furthermore, if the citric acid ingredient in these products is functioning as a preservative, the preservative function must be declared in accordance with 21 CFR 101.22(j).
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 your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address 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 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
We offer the following labeling comments:
• The Poppy Coffee Cake, Hazelnut Coffee Cake, Marzipan Coffee Cake and Banana Nut Sweet Bread products fail to properly declare the food source of a major food allergen, i.e., specific tree nuts, in the Contains statement.
• FDA advises that your allergen advisory labeling should not be used as a substitute for adherence to current Good Manufacturing Practices (CGMPs) or Preventive Controls (21 CFR 117) and any allergen advisory statement that is used must be truthful and not misleading.
• If the products are for retail sale, section 21 CFR 101.7(p) states that an accurate statement of the net quantity of contents in terms of the metric system of weight or measure may also appear on the principal display panel or on other panels.
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
19701 Fairchild
Irvine, CA 92612
Refer to Unique Identification Number
681329
when replying.
If you 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 Kimberly M. Lichter, Compliance Officer, at kimberly.lichter@fda.hhs.gov or (949) 608-2967.
Sincerely,
/S/
Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations – West Division 5
Content current as of:
10/01/2024
Regulated Product(s)
Food & Beverages