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Thursday, October 31, 2024

How many companies in cities across Miami-Dade County received FDA citations in Q3?

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

There were seven companies in a city associated with Miami-Dade County that received FDA citations as a result of seven inspections conducted in the county over the third quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 12.5% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

  • You did not conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product you process.
  • You did not implement the monitoring, recordkeeping and verification procedures listed in your HACCP plan.
  • Your HACCP plan does not list the food safety hazards that are reasonably likely to occur.

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

Of the companies cited, six should take voluntary actions to correct their managing operations (85.7%). Additionally, one company had to take regulatory and/or administrative actions (14.3%).

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.

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, according to its website.

Companies located within Miami-Dade County Cities and the citations they received in Q3
Company NameArea of BusinessInspection DateIssue Cited
Alfa Vitamins Laboratories, Inc.Food and Cosmetics07/17/2024Cleaning compounds and toxic materials - holding
Alfa Vitamins Laboratories, Inc.Food and Cosmetics07/17/2024Hand-washing facilities
Alfa Vitamins Laboratories, Inc.Food and Cosmetics07/17/2024Specifications-component purity, strength, composition
Alfa Vitamins Laboratories, Inc.Food and Cosmetics07/17/2024Specifications - identity, purity, strength, composition
Alfa Vitamins Laboratories, Inc.Food and Cosmetics07/17/2024Master manufacturing record - each batch
Alfa Vitamins Laboratories, Inc.Food and Cosmetics07/17/2024Packaging description, representative label
Alfa Vitamins Laboratories, Inc.Food and Cosmetics07/17/2024Written procedures - laboratory operations
Alfa Vitamins Laboratories, Inc.Food and Cosmetics07/17/2024Hold - temperature, humidity, light
Cubanita Frozen Foods CorporationFood and Cosmetics07/12/2024Personnel
Cubanita Frozen Foods CorporationFood and Cosmetics07/12/2024Pest control
Cubanita Frozen Foods CorporationFood and Cosmetics07/12/2024Manufacturing, processing, packing, holding - Controls
Cubanita Frozen Foods CorporationFood and Cosmetics07/12/2024Food safety plan
Interfood Trading Group, Inc.Food and Cosmetics07/09/2024Develop FSVP
Interfood Trading Group, Inc.Food and Cosmetics07/09/2024Record - available
LEASA Industries Company, Inc.Food and Cosmetics07/26/2024Equip & tools - cleanability
LEASA Industries Company, Inc.Food and Cosmetics07/26/2024Written environmental monitoring plan
Newpharma, Inc.Food and Cosmetics07/01/2024Quality control - production, process control
Newpharma, Inc.Food and Cosmetics07/01/2024Quality control - reject; specification not met
Newpharma, Inc.Food and Cosmetics07/01/2024Written procedures - packaging
Ocho Rios-Miami, Inc.Food and Cosmetics07/16/2024Hazard analysis
Ocho Rios-Miami, Inc.Food and Cosmetics07/16/2024HACCP plan implementation
Ocho Rios-Miami, Inc.Food and Cosmetics07/16/2024Food safety hazards
Ocho Rios-Miami, Inc.Food and Cosmetics07/16/2024Verification - record review - frequency
Perez Lab, Inc.Food and Cosmetics09/06/2024Instruments - calibration
Perez Lab, Inc.Food and Cosmetics09/06/2024Make and keep records - equipment and utensils
Perez Lab, Inc.Food and Cosmetics09/06/2024Specifications - components
Perez Lab, Inc.Food and Cosmetics09/06/2024Specifications - labels, packaging
Perez Lab, Inc.Food and Cosmetics09/06/2024Specifications - finished dietary supplement
Perez Lab, Inc.Food and Cosmetics09/06/2024Component - verify identity, dietary ingredient
Perez Lab, Inc.Food and Cosmetics09/06/2024Specifications met - verify; finished batch
Perez Lab, Inc.Food and Cosmetics09/06/2024Documentation - requirements
Perez Lab, Inc.Food and Cosmetics09/06/2024Master manufacturing record - prepared
Perez Lab, Inc.Food and Cosmetics09/06/2024Master manufacturing record - record requirements
Perez Lab, Inc.Food and Cosmetics09/06/2024Batch record - required information

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