Medina’s Inc. Warned for Misbranding and Missing Allergens

The FDA conducted an inspection at Medina’s Baking and Powder Products Inc. from August 31st, 2021 thru September 14th, 2021.  The inspections focused mainly on the liquid flavors and found serious violations at the food manufacturing facility.  The two main violations were around preventative control violations and misbranding, both of which is discussed in the warning letter released.

So now let’s dive into the violations listed.

  1. CFR 117.130 requires that a food manufacturing facility identify and evaluate allergens present in the ingredients at the facility, including undeclared. The FDA reiterated that a food manufacturing facility must establish preventative controls to address hazards present.  These would include but are not limited to procedures, processes, and practices employed in the labeling program to ensure that all food allergens are included on the label. This was not the case for Medina’s vanilla Flavor Imitation (White) and Chocolate Flavor products, due in part to undeclared egg. The deficiency was revealed when FDA investigators observed that Mantecado Flavor contains sugar yolks, which contain egg. This allergen was not declared on the label resulting in a recall.
  2. The FDA also stated that there were misbranding violations during the inspections.
    • Medina brand Marsh-Mallow No. 2 Meringue is misbranded due to failure to list the allergen statement in Spanish when it is a bilingual label which is required by 21 CFR 101.15(c)(1). It also didn’t list the statement of identity in English alongside the name in Spanish.
    • The Medina brand Vanilla Flavor Imitation (White), Artificial Flavor Mantecado, and Marsh-Mallow No. 2 Meringue products are misbranded within the meaning of CFR 101.4 which specifically addresses when products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label.  One of the examples given in the warning letter is “Vegetable Gum” and “Gum” are not the common or usual names for those types of ingredients. The FDA noted 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.  The labels also failed to list some of the ingredients in the formulations. For example, 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 which is required per regulations.
    • Other violations included misspelling, net quantity errors, as well as several  other common/usual name errors in the ingredient statement

To read the letter in full, click HERE.

If anything in the letter sounds familiar from your facility, or you would just like to be better prepared for your own FDA inspection when the time comes, let us know. In addition to label compliance reviews, we do facility audits and consulting on following cGMPs. Contact us today to discuss your needs and get a free quote.