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Monday, November 4, 2024

FDA issued 18 citations in cities across Maricopa County in January

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Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

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

This is a 200% increase over the number of companies cited in the previous month.

The citations in the county include:

  • You did not establish an identity specification for each component.
  • You did not establish component specifications for purity, strength and composition.
  • You did not establish product specifications for the of the finished dietary supplement.

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

Of the companies cited, three should take voluntary actions to correct their managing operations. 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.

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 Maricopa County Cities and the citations they received in January
Company NameArea of BusinessInspection DateIssue Cited
Adept Life Science, LLCFood and Cosmetics01/25/2024Specifications - component identity
Adept Life Science, LLCFood and Cosmetics01/25/2024Specifications-component purity, strength, composition
Adept Life Science, LLCFood and Cosmetics01/25/2024Specifications - identity, purity, strength, composition
Adept Life Science, LLCFood and Cosmetics01/25/2024Processes, specifications, written procedures
Adept Life Science, LLCFood and Cosmetics01/25/2024QC operations - master manufacturing record, modifications
Adept Life Science, LLCFood and Cosmetics01/25/2024Quality control operations - batch production records
Adept Life Science, LLCFood and Cosmetics01/25/2024Quality control - components, identity specifications
Adept Life Science, LLCFood and Cosmetics01/25/2024Master manufacturing record - each batch
Adept Life Science, LLCFood and Cosmetics01/25/2024Batch record - complete
Elote Blanco Mexicano, LLCFood and Cosmetics01/19/2024Hazard analysis biological, chemical, physical
Elote Blanco Mexicano, LLCFood and Cosmetics01/19/2024Evaluation - performance, risk
Elote Blanco Mexicano, LLCFood and Cosmetics01/19/2024Supplier verification - establish written procedures
Elote Blanco Mexicano, LLCFood and Cosmetics01/19/2024Verification activity frequency
Elote Blanco Mexicano, LLCFood and Cosmetics01/19/2024Verification activity before import, periodically
Sage & Sand Potato Processing Company, Inc.Food and Cosmetics01/19/2024Grounds
Sage & Sand Potato Processing Company, Inc.Food and Cosmetics01/19/2024Sanitary operations - Plant maintenance
Sage & Sand Potato Processing Company, Inc.Food and Cosmetics01/19/2024Equipment and utensils - Design and maintenance
Sage & Sand Potato Processing Company, Inc.Food and Cosmetics01/19/2024Manufacturing, processing, packing, holding - Controls

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