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Thursday, November 14, 2024

FDA: 1 company in cities within Hubbard County received 5 citations in 2023

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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 was one company in a city associated with Hubbard County that received FDA citations as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous year.

The citations in the county include:

  • You did not establish product specifications for the identity, purity, strength and composition of the finished dietary supplement.
  • You did not retain reserve samples for the required time.
  • You did not make and keep written procedures for fulfilling the requirements that apply to product received for packaging or labeling as a dietary supplement and for distribution rather than for return to the supplier.

The company cited should take a voluntary action to correct its 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.

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 Hubbard County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
MN Emu, LLCFood and Cosmetics09/29/2023Specifications - identity, purity, strength, composition
MN Emu, LLCFood and Cosmetics09/29/2023Reserve sample - retained
MN Emu, LLCFood and Cosmetics09/29/2023Written procedures - product received
MN Emu, LLCFood and Cosmetics09/29/2023Records - packaging, labeling operations
MN Emu, LLCFood and Cosmetics09/29/2023Insanitary conditions; contaminated with filth

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