How many companies in cities across Miami-Dade County received FDA citations in Q1?

How many companies in cities across Miami-Dade County received FDA citations in Q1?
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA — Official Website
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There were three companies in cities associated with Miami-Dade County that received FDA citations as a result of three inspections conducted in the county over the first quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 66.7% decrease from the number of companies cited in the previous quarter.

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.

Most of the companies cited were involved in the Food and Cosmetics sector.

Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).

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.

Companies located within Miami-Dade County Cities and the citations they received in Q1
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
Shagalla, Inc. Food and Cosmetics 02/24/2025 HACCP plan implementation
Shagalla, Inc. Food and Cosmetics 02/24/2025 HACCP plan location
Shagalla, Inc. Food and Cosmetics 02/24/2025 Signed and dated
Shagalla, Inc. Food and Cosmetics 02/24/2025 Sanitation monitoring
Shagalla, Inc. Food and Cosmetics 02/24/2025 Importer verification


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