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Sunday, December 22, 2024

FDA issued 23 citations in cities across Miami-Dade County in July

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Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

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

This is a 100% increase over the number of companies cited in the previous month.

The citations in the county include:

  • You did not identify and hold cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, or other toxic materials in a manner that protects against contamination of components, dietary supplements, or contact surfaces.
  • Your hand-washing facilities are not adequate and do not furnish running water at a suitable temperature.
  • You did not establish component specifications for strength and composition.

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

Of the companies cited, five should take voluntary actions to correct their managing operations (83.3%). Additionally, one company had to take regulatory and/or administrative actions (16.7%).

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 July
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

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