FDA WARNING_LETTER - Medina Baking and Powder Products, Inc. - September 14, 2021

The FDA inspected a food manufacturing facility at 1864 NW 22 St., Miami, FL, from August 31 to September 14, 2021, focusing on liquid food flavors. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR part 117), leading to an FDA Form 483.

Key violations include: 1. **Preventive Controls:** Failure to identify and evaluate undeclared allergens (egg) as a known or reasonably foreseeable hazard requiring a preventive control in liquid food flavors like Vanilla Flavor Imitation (White) and Chocolate Flavor. This led to a recall on September 9, 2021. The firm's response to update labels was noted, but a revised hazard analysis or new preventive control procedure was not provided. 2. **Misbranding (Section 403 of the Act):** * Medina brand Marsh-Mallow No. 2 Meringue and Artificial Flavor Mantecado products lacked required Spanish ingredient and "contains" statements, or English statement of identity, respectively. * Medina brand Vanilla Flavor Imitation (White), Artificial Flavor Mantecado, and Marsh-Mallow No. 2 Meringue products failed to declare common or usual names for ingredients (e.g., "vegetable gum" instead of