Miami Courant

There were two companies in cities associated with Miami-Dade County that received FDA citations as a result of two inspections conducted in the county in January, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 75% decrease from the number of companies cited in the previous month.

The citations in the county include:

• The responsibilities and procedures applicable to the quality control unit are not in writing.
• Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Routine calibration of equipment is not performed according to a written program designed to assure proper performance.

The companies cited were involved in either Drugs or Food and Cosmetics sectors.

Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality.

Company Name	Area of Business	Inspection Date	Issue Cited
Cordoba Foods, LLC	Food and Cosmetics	01/31/2025	Process filing
Cordoba Foods, LLC	Food and Cosmetics	01/31/2025	Quality control procedures
Cordoba Foods, LLC	Food and Cosmetics	01/31/2025	Code - required elements
Cordoba Foods, LLC	Food and Cosmetics	01/31/2025	Process deviations- identification and records
Cordoba Foods, LLC	Food and Cosmetics	01/31/2025	Pest control
Cordoba Foods, LLC	Food and Cosmetics	01/31/2025	Hazard analysis - Identification of hazard
Evi Labs	Drugs	01/15/2025	Procedures not in writing, fully followed
Evi Labs	Drugs	01/15/2025	Cleaning / Sanitizing / Maintenance
Evi Labs	Drugs	01/15/2025	Calibration/Inspection/Checking not done
Evi Labs	Drugs	01/15/2025	Computer control of master formula records
Evi Labs	Drugs	01/15/2025	Reports of Analysis (Components)
Evi Labs	Drugs	01/15/2025	Control procedures to monitor and validate performance
Evi Labs	Drugs	01/15/2025	Scientifically sound laboratory controls
Evi Labs	Drugs	01/15/2025	Testing and release for distribution
Evi Labs	Drugs	01/15/2025	Lack of written stability program
Evi Labs	Drugs	01/15/2025	Dates not included for each significant step