KC Reporter

There were four companies in cities associated with Platte County that received FDA citations as a result of four inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous year.

The citations in the county include:

• You did not establish an identity specification for each component.
• You did not establish component specifications for purity and strength.
• You did not establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement.

All of the companies cited were involved in either Food and Cosmetics, Devices, Veterinary, or Drugs sectors.

All of the companies cited should take voluntary actions to correct their managing operations.

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
Hansen Mueller Company Kansas City	Veterinary	05/03/2024	Individual/Employee Qualifications
Hansen Mueller Company Kansas City	Veterinary	05/03/2024	Sanitation
Hansen Mueller Company Kansas City	Veterinary	05/03/2024	Protein blenders, feed manufacturers, distributors
Hansen Mueller Company Kansas City	Veterinary	05/03/2024	Separate equipment and facilities or adequate cleanout
Hyalogic, LLC	Food and Cosmetics	07/25/2024	Specifications - component identity
Hyalogic, LLC	Food and Cosmetics	07/25/2024	Specifications-component purity, strength, composition
Hyalogic, LLC	Food and Cosmetics	07/25/2024	Specifications - contamination limits
Hyalogic, LLC	Food and Cosmetics	07/25/2024	Specifications - contamination limits
Hyalogic, LLC	Food and Cosmetics	07/25/2024	Specifications - finished packaging, labeling
Hyalogic, LLC	Food and Cosmetics	07/25/2024	Quality control - basis; tests, examinations
Hyalogic, LLC	Food and Cosmetics	07/25/2024	Master manufacturing record - specifications; quality
Hyalogic, LLC	Food and Cosmetics	07/25/2024	Master manufacturing record theoretical and expected yield
Hyalogic, LLC	Food and Cosmetics	07/25/2024	Batch record - every batch
Hyalogic, LLC	Food and Cosmetics	07/25/2024	Hold - temperature, humidity, light
Nostrum Laboratories, Inc.	Drugs	09/20/2024	Failure to develop written procedures
Nostrum Laboratories, Inc.	Drugs	09/20/2024	Late submission of 15-day report
Southwest Technologies, Inc.	Devices	05/16/2024	Process changes - review, evaluation and revalidation