Memphis Standard

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

The citations in the county include:

• You did not establish in-process specifications for a point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for identity, purity, strength and composition.
• You did not establish label and packaging specifications.
• You did not establish product specifications for the identity, purity, strength and composition of the finished dietary supplement.

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
CE-Bio, LLC	Food and Cosmetics	12/06/2023	In-process identity, purity, strength, composition
CE-Bio, LLC	Food and Cosmetics	12/06/2023	Specifications - labels, packaging
CE-Bio, LLC	Food and Cosmetics	12/06/2023	Specifications - identity, purity, strength, composition
CE-Bio, LLC	Food and Cosmetics	12/06/2023	Quality control - dietary supplement; adulteration
CE-Bio, LLC	Food and Cosmetics	12/06/2023	Batch record - complete