Omaha City Wire

There was one company in a city associated with Douglas County that received FDA citations as a result of one inspection conducted in the county over the second quarter of 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 quarter.

The citations in the county include:

• You did not establish a specification for a point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.
• You did not establish and follow written procedures for quality control operations for conducting a material review and making a disposition decision.
• You did not establish and follow written procedures for quality control operations.

The company cited was involved in the Food and Cosmetics sector.

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.

Company Name	Area of Business	Inspection Date	Issue Cited
New Dawn Nutrition, Inc.	Food and Cosmetics	05/03/2024	Specifications - manufacturing process
New Dawn Nutrition, Inc.	Food and Cosmetics	05/03/2024	Written procedure quality control operations material review
New Dawn Nutrition, Inc.	Food and Cosmetics	05/03/2024	Written procedures - quality control operations
New Dawn Nutrition, Inc.	Food and Cosmetics	05/03/2024	Quality control - reject; specification not met
New Dawn Nutrition, Inc.	Food and Cosmetics	05/03/2024	Written procedures - packaging, labeling received
New Dawn Nutrition, Inc.	Food and Cosmetics	05/03/2024	Master manufacturing record - unique formulation
New Dawn Nutrition, Inc.	Food and Cosmetics	05/03/2024	Batch record - label
New Dawn Nutrition, Inc.	Food and Cosmetics	05/03/2024	Labels - issuance, use