- Delivery Method:
- Electronic Mail
- Food & Beverages
Recipient NameMr. Roberto Martin
- Medina Baking and Powder Products, Inc.
1864 NW 22 St.
Miami, FL 33142
- Issuing Office:
- Office of Human and Animal Food Operations Division IV East
March 4, 2022
22-HAFE4-WL-03/CMS No. 619373
The United States Food and Drug Administration (FDA) inspected your facility located at 1864 NW 22 St., Miami, FL 33142 from August 31, 2021 to September 14, 2021. Your facility manufactures food products including liquid flavors, marshmallow powder, and ice cream stabilizer. Our inspection focused on liquid food flavors and 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 (CFR), part 117 (21 CFR part 117). At the conclusion of the inspection, FDA issued an FDA Form 483, Inspectional Observations, listing the deviations found at your facility.
Based on FDA’s inspectional findings, we 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)). Further, during the inspection, you revised your labels to include the allergens and colors used in the production of many of your products; however, several of your products with revised labels (i.e., Medina brand Vanilla Flavor Imitation (White), Artificial Flavor Mantecado, and Marsh-Mallow No. 2 Meringue) remain misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343). 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.
We received your firm’s written response to the FDA Form 483 dated September 24, 2021, which included a description of your corrective actions taken and planned. After reviewing the inspectional findings and your response to the observations listed in the FDA Form 483, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We address your response below.
Preventive Controls (21 CFR part 117, Subpart C)
You did not identify and evaluate undeclared allergens due to an incorrect label as a known or reasonably foreseeable hazard to determine whether the hazard requires a preventive control in your allergen-containing liquid food flavors, as required by 21 CFR 117.130(a)(1). Specifically, your hazard analysis for “(b)(4)” did not consider undeclared allergens, but your Vanilla Flavor Imitation (White) and Chocolate Flavor both contain egg (a major food allergen). 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)). You did not have such controls in place as evidenced by your September 9, 2021, recall of your Vanilla Flavor Imitation (White) and Chocolate Flavor products, due in part to undeclared egg. The deficiency was revealed when FDA investigators observed that your Mantecado Flavor contains sugar yolks, which contain egg. Your Mantecado Flavor is used as an ingredient in your Chocolate Flavor, which is used as an ingredient in your Vanilla Flavor Imitation (White). However, until the FDA inspection, you were not declaring the egg allergen on product labels for Vanilla Flavor Imitation (White) or Chocolate Flavor.
In your written response, you stated that your labels for the Vanilla Flavor Imitation (White) and Chocolate Flavor will be updated to include allergens and promised to complete a label review and document the label review for any future products made to ensure compliance. We will review the adequacy of your labeling corrective actions during the next inspection. Your written response did not include a revised hazard analysis or new preventive control procedure to ensure control of the undeclared allergen hazard.
1. Your Medina brand Marsh-Mallow No. 2 Meringue product is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the label contains statements in Spanish but does not contain an ingredient statement and “contains” statement in Spanish, as required by 21 CFR 101.15(c)(2). Further, your Artificial Flavor Mantecado product is misbranded within the meaning of section 403(f) of the Act because it does not contain a statement of identity in English, as required by 21 CFR 101.15(c)(1).
2. Your Medina brand Vanilla Flavor Imitation (White), Artificial Flavor Mantecado, and Marsh-Mallow No. 2 Meringue 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 is not declared on the label, as required by 21 CFR 101.4. Specifically:
a. “Vegetable Gum” and “Gum” are not the common or usual names for these ingredients. We note that the flavor formulations include Xanthan gum and Tragacanth gum; however, the ingredient lists declare “vegetable gum.” There is no provision in 21 CFR 101.4(b) for the generic term “vegetable gum,” nor for the collective listing of gum ingredients. For the Marsh-Mallow No. 2 Meringue product, we note that the ingredient list declares “Tragacanth, Gum”; it is unclear whether this is a typographical error with a misplaced comma or is intended to refer to two ingredients.
b. The labels fail to list some of the ingredients in the formulations. For example, based on the formulations provided, the Medina brand Vanilla Flavor Imitation (White) contains sugar and honey and the Mantecado formulation contains sugar; however, these ingredients are not declared in the respective ingredient lists.
c. The formulations for both flavor products (Medina brand Vanilla Flavor Imitation (White) and the Artificial Flavor Mantecado) include the ingredient “Benzo dihydro pyrone dolcotone.” Based on the photo of the label of this ingredient, the name is Benzodihydropyrone. The Mantecado label declares the ingredient as “dolocotone” and the Vanilla flavor does not declare this specific ingredient. Additional names for this ingredient are found here: https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=FoodSubstances&id=DIHYDROCOUMARIN. “Dolocotone” is not an appropriate common or usual name for an ingredient.
d. The formulation for the Marsh-Mallow No. 2 Meringue includes the ingredient “Clearjel,” which is modified corn starch; however, the ingredient label declares “starch,” which is not the appropriate common or usual name for modified corn starch.
e. The ingredients on the Marsh-Mallow No. 2 Meringue label are not declared in descending order of predominance based on the formulation. For example, according to your (b)(4) record, the amount of salt used in the product is “(b)(4)” of a bag which weighs (b)(4) pounds, resulting in (b)(4) pounds of salt. Your product label lists salt after ingredients such as Ethyl Vanillin and Vanillin which are less than (b)(4) pounds each in the formulation.
3. Your Artificial Flavor Mantecado product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7. The label includes two different net quantity declarations, “(b)(4)” and below that, “(b)(4)”. The net quantity of contents must be accurate; therefore, a label cannot declare two different net quantities.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
We note that “Vanillin” is misspelled as “Vainillin” twice on the Mantecado label. We also note that “Latose” on the Marsh-Mallow No. 2 Meringue label likely is intended to refer to “Lactose.”
Please notify FDA in writing, within 15 working days of the receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the timeframe within which you will do so.
Please send your reply to the Food and Drug Administration, attention of: Mr. Ramon A. Hernandez, Program Division Director, 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901. If you have questions regarding this letter, please contact Mr. Donald J. Mee, Compliance Officer, at (904) 353-4560 Ext. 114, or via e-mail at firstname.lastname@example.org.
Ramon A. Hernandez
District Director, San Juan District Office
Program Division Director,
Office of Human and Animal Food Operations
Division IV East