Environmental pathogens considered a hazard requiring a preventive controls - The facility did not identify and evaluate recontamination with environmental pathogens as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. The RTE bakery products are exposed to the environment at post-baking steps at the (b)(4) steps where they can be contaminated with environmental pathogens such as Salmonella and Listeria monocytogenes. The packaged bakery products do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. Therefore, contamination with environmental pathogens is a known or reasonably foreseeable hazard
Environmental monitoring is required - 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 is not monitoring the environment for an environmental pathogen, or for an appropriate indicator organism, to verify the effectiveness of your sanitation controls.
Need to consider mycotoxins as a hazard in the hazard analysis - The facility did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. The facility manufactures RTE bakery products (e.g., breads) containing high protein wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON). Therefore, 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 this ingredient. 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). This program was not in place.
Allergen labeling is required - The facility’s written hazard analysis considered undeclared allergens; however, the company determined this to be the responsibility of the customer and the consumer. The facility manufactures finished products that contain allergens such as wheat, milk, egg, soy (soybean lecithin), coconut, walnuts, and sesame. They are distributed to restaurants, hotels, nursing homes, hospitals, and distributors/wholesalers with labeling that does not include an ingredient statement and allergen declaration. Examples - the challah burger buns, challah knot rolls, and sesame challah burger buns were staged for distribution in the staging area. They were packaged in pre-printed plastic bags without the wheat, soy, and sesame allergens declared. The 12-inch hoagie rolls were staged for distribution in the staging area. They were packaged in clear plastic bags that did not declare wheat and soy allergens.
Allergen controls for cleaning to prevent cross contact - Allergen controls procedures for nuts do not ensure protection of food from allergen cross-contact from walnuts, as required by 21 CFR 117.135(c)(2)(i). Specifically, the hazard analysis for various RTE breads, cakes, and pastries identified the hazard of allergen cross-contact at the (b)(4) steps. At these steps, they use shared food-contact equipment and utensils to manufacture bakery products containing different allergen profiles on the same day.
The written allergen preventive control procedure states that “(b)(4)”. However, this procedure was not followed. On October 30, 2023, the rotating round turntable and utensils used by the employee were not cleaned after handling the RTE pina colada cake (containing wheat, soy, eggs, milk and coconut) and before handling the RTE mocha cake (containing wheat, soy, eggs, and milk but not coconut).
GMP Issues
- A pastry area employee walked outside the firm to her car wearing her hairnet and plastic work apron. She returned to the pastry area without washing her hands or replacing her hairnet and plastic apron.
- A cake room employee wearing a hairnet, gloves, and plastic apron was observed preparing raw chocolate cigars. He exited the cake room door leading to the outside. A few moments later he returned through the same exterior door wearing a hairnet, gloves, apron, and the facemask. He immediately returned to preparing raw chocolate cigars without washing his hands and changing his hairnet, gloves, and plastic apron.
- A bearded pastry area employee mixing RTE frosting/icing was using his gloved hand to transfer the frosting to another bowl. While he was transferring the frosting, part of his bare arm/arm hair came in direct contact with the frosting. Also, this employee was wearing a beard cover; however, it was pulled down under his chin during the transferring of the frosting.
- In your pastry room and cake room, employees did not wash their hands or gloves after touching their face.
- Open beverage bottles were observed 1) In the bread processing area, under the preparation tables, while the employees were manipulating raw dough; 2) In the pastry area, under preparation tables, while the employees were manipulating in-process products; 3) Inside the pastry area reach-in freezer, where ingredients, in-process, and finished products are stored.
- In the cake room, your facility has a black multi-drawer toolbox where utensils (e.g., spatulas, knives, cake cutting wire) are stored after they are cleaned. These utensils are taken from the toolbox and immediately used to decorate and cut RTE cake room products. The toolbox contained personal items such as glasses, keys, and opened beverage bottles.
- The plant was not maintained in a clean and sanitary condition and in adequate repair, as required by 21 CFR 117.35(a). Specifically: a. the fluorescent light located directly above the processing tables appeared to have a black mold-like substance on the light diffusers. Adjacent ceiling tiles were also observed with an apparent similar substance, and b. On two large fans in the cutting and packing room were observed to have excessive filth and debris on the metal wire fan guard. The fans were observed blowing onto RTE uncovered cupcakes on a pan rack cart.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mena-food-group-llc-673814-08082024
Mena Food Group, LLC
MARCS-CMS 673814 — August 08, 2024
Mena Food Group, LLC
MARCS-CMS 673814 — August 08, 2024
Recipient:
Mr. David Mena
Owner/President
Mena Food Group, LLC
4710 NW 15th Ave Ste 5a-2
Fort Lauderdale, FL 33309-3785
United States
david@bakerymilitellos.co
Issuing Office:
Office of Regulatory Affairs
United States
WARNING LETTER
24-HAFE4-WL-04 / CMS No. 673814
Dear Mr. Mena:
The United States Food and Drug Administration (FDA) inspected your facility located at 4710 NW 15th Ave Ste 5a-2, Fort Lauderdale, FL from October 30, 2023, to November 20, 2023. Your facility manufactures ready-to eat (RTE) bakery products including breads, cakes, and pastries. During our inspection of your facility, FDA investigators found 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 determined that your food 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 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)).
Furthermore, during this inspection, our investigators obtained product labeling and ingredient information for several of your RTE bakery products. We have reviewed these documents and found the products that you manufacture and distribute are not labeled in accordance with the Code of Federal Regulations, Title 21, Part 101, Food Labeling Regulation (21 CFR Part 101). Therefore, your RTE bakery products are misbranded within the meaning of Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 343, in that they are not labeled with the mandatory information required by the Act.
You may find the Act and further information about the CGMP & PC rule through links in FDA's home page at http://www.fda.gov.
At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at your firm. However, to date, we have not received your written response to the issued FDA 483 describing corrective actions taken by your firm. We are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
1. You did not identify and evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control for your RTE breads, cakes, and pastries, as required by 21 CFR 117.130(a)(1). Specifically:
a. You did not identify and evaluate recontamination with environmental pathogens as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. Your RTE bakery products are exposed to the environment at post-baking steps at the (b)(4) steps where they can be contaminated with environmental pathogens such as Salmonella and Listeria monocytogenes. The packaged bakery products do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. Therefore, contamination with environmental pathogens is a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as requiring a preventive control. Preventive 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 (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 is not monitoring the environment for an environmental pathogen, or for an appropriate indicator organism, to verify the effectiveness of your sanitation controls.
b. 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 (e.g., breads) containing high protein wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON). Therefore, 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 this ingredient. 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.
2. You did not appropriately evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control in your RTE breads, cakes, and pastries, as required by 21 CFR 117.130(a)(1). Specifically, your facility’s written hazard analysis considered undeclared allergens; however, you determined this to be the responsibility of your customer and the consumer. Your facility manufactures finished products that contain allergens such as wheat, milk, egg, soy (soybean lecithin), coconut, walnuts, and sesame. They are distributed to restaurants, hotels, nursing homes, hospitals, and distributors/wholesalers with labeling that does not include an ingredient statement and allergen declaration. Foods containing allergens can cause serious adverse health consequences or death to allergic individuals if they consume a food to which they are allergic. A knowledgeable person manufacturing/processing food in your circumstances would identify food allergens as hazards requiring a preventive control. Preventive controls for food allergens include procedures, practices, and processes employed for labeling to ensure that all food allergens are included on the label (see 21 CFR 117.135(c)(2)(ii)). We note the following with regard to your allergen labeling:
a. On November 13, 3023, challah burger buns, challah knot rolls, and sesame challah burger buns were staged for distribution in your staging area. They were packaged in pre-printed plastic bags without the wheat, soy, and sesame allergens declared.
b. On November 13, 3023, 12-inch hoagie rolls were staged for distribution in your staging area. They were packaged in clear plastic bags that did not declare wheat and soy allergens.
3. Your allergen controls procedures for nuts do not ensure protection of food from allergen cross-contact from walnuts, as required by 21 CFR 117.135(c)(2)(i). Specifically, your hazard analysis for various RTE breads, cakes, and pastries identified the hazard of allergen cross-contact at the (b)(4) steps. At these steps, you use shared food-contact equipment and utensils to manufacture bakery products containing different allergen profiles on the same day. However, your written preventive control program procedures do not include monitoring, corrective actions, and verification to control the hazard and you do not have records documenting activities performed. In addition, your allergen procedures for nuts do not include coconut, which is an allergen.
In addition, your written allergen preventive control procedure states that “(b)(4)”. However, this procedure was not followed. On October 30, 2023, the rotating round turntable and utensils used by your employee were not cleaned after handling the RTE pina colada cake (containing wheat, soy, eggs, milk and coconut) and before handling the RTE mocha cake (containing wheat, soy, eggs, and milk but not coconut).
Current Good Manufacturing Practice (Subpart B):
You did not take reasonable measures and precautions to ensure that all persons working in direct contract with food, food-contact surfaces, and food packaging materials conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR 117.10(b). Specifically, on October 30, 2023, during the manufacturing of various RTE breads, cakes, and pastries:
a. A pastry area employee walked outside the firm to her car wearing her hairnet and plastic work apron. She returned to the pastry area without washing her hands or replacing her hairnet and plastic apron.
b. A cake room employee wearing a hairnet, gloves, and plastic apron was observed preparing raw chocolate cigars. He exited the cake room door leading to the outside. A few moments later he returned through the same exterior door wearing a hairnet, gloves, apron, and the facemask. He immediately returned to preparing raw chocolate cigars without washing his hands and changing his hairnet, gloves, and plastic apron.
c. A bearded pastry area employee mixing RTE frosting/icing was using his gloved hand to transfer the frosting to another bowl. While he was transferring the frosting, part of his bare arm/arm hair came in direct contact with the frosting. Also, this employee was wearing a beard cover; however, it was pulled down under his chin during the transferring of the frosting.
d. In your pastry room and cake room, employees did not wash their hands or gloves after touching their face.
e. Open beverage bottles were observed:
1) In the bread processing area, under the preparation tables, while the employees were manipulating raw dough.
2) In the pastry area, under preparation tables, while the employees were manipulating in-process products.
3) Inside the pastry area reach-in freezer, where ingredients, in-process, and finished products are stored.
f. In your cake room, your facility has a black multi-drawer toolbox where utensils (e.g., spatulas, knives, cake cutting wire) are stored after they are cleaned. These utensils are taken from the toolbox and immediately used to decorate and cut RTE cake room products. The toolbox contained personal items such as glasses, keys, and opened beverage bottles.
2. You did not maintain your plant in a clean and sanitary condition and in adequate repair, as required by 21 CFR 117.35(a). Specifically:
a. Your firm assembles RTE cakes and pastry items inside the cake room. On October 30, 2023, the fluorescent light located directly above the processing tables appeared to have a black mold-like substance on the light diffusers. Adjacent ceiling tiles were also observed with an apparent similar substance.
b. On October 30, 2023, two large fans in the cutting and packing room were observed to have excessive filth and debris on the metal wire fan guard. You use these fans to help cool down the RTE baked products. The fans were observed blowing onto RTE uncovered cupcakes on a pan rack cart.
Misbranding Violations:
1. Your Assorted Cupcakes, Challah Burger Buns with Sesame, Challah Hoagies, and Chocolate Peanut Butter Cake products are misbranded within the meaning of Section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare individual major food allergens, as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils as “major food allergens.” A food is misbranded under section 403(w) of the Act 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:
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
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 (e.g., “Whey (Milk)”), except 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 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)].
Specifically, your Assorted Cupcakes product is manufactured with milk, soy, egg, and wheat. Your Challah Burger Buns with Sesame and Challah Hoagies products are manufactured with wheat and soy. The Challah Burger Buns with Sesame are further manufactured with sesame. Your Chocolate Peanut Butter Cake product is manufactured with, at minimum, peanuts, and potentially other major food allergens. These major food allergens are not listed on your finished product labels.
2. Your Assorted Cupcakes Challah Burger Buns with Sesame, Challah Hoagies, and Chocolate Peanut Butter Cake products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient and sub-ingredient is not declared on the label, as required under 21 CFR 101.4. Specifically, these products are not labeled with an ingredient statement.
3. Your Assorted Cupcakes product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. §343(k)] in that the vanilla cupcakes and frostings used for both vanilla and chocolate cupcakes contain color additives, but the label fails to declare the presence of color additives as required by 21 CFR 101.22(k).
4. Your Challah Burger Buns with Sesame and Challah Hoagies 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, if any, fail to bear the common or usual name of the food as required by 21 CFR 101.3.
5. Your Assorted Cupcakes, Challah Burger Buns with Sesame, Challah Hoagies, and Chocolate Peanut Butter Cake products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).
Specifically, your Assorted Cupcakes and Chocolate Peanut Butter Cake products are labeled with your firm’s dba name but not the street address, city, state, or ZIP code. Your Challah Burger Buns with Sesame and Challah Hoagies are not labeled.
We note that the street address may be omitted if it is shown in a current city directory or telephone directory. Further, in the case of non-consumer packages, the requirement for listing the zip code may be met with declaration on the label or on the labeling (including invoice).
6. Your Assorted Cupcakes, Challah Burger Buns with Sesame, Challah Hoagies, and Chocolate Peanut Butter Cake products are misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because they fail to bear an accurate statement of the net quantity of contents, as required by 21 CFR 101.7.
This letter is not intended to be an all-inclusive statement of violations that may exist 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, 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 also offer the following comment regarding your Assorted Cupcakes product: “Cupcakes Asst” is not an appropriate common or usual name for the product as required by 21 CFR 101.3.
Your written response should be directed to the U.S. Food and Drug Administration, attention to: Mr. Ramon A. Hernandez, Program Division Director, HAFE4, 466 Ave. Fernández Juncos, San Juan, Puerto Rico 00901-3223. You may email a copy of your response with appropriate attachments to the email address: orahafeast4firmresponses@fda.hhs.gov. If you have any questions regarding this letter, please contact, Ms. Gina Eng, Compliance Officer, at (240) 753-3935 or via email at Gina.Eng@fda.hhs.gov.
Sincerely,
/S/
Ramon A. Hernandez
Program Division Director
Office of Human and Animal Food Operations
East IV Division
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