Grayson Times

There was one company in a city associated with Grayson County that received FDA citations as a result of one inspection conducted in the county over the first 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:

• The written instructions in your master manufacturing record did not include instructions for corrective action plans to use when specifications are not met.
• Your batch production records did not include an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record.
• You did not establish laboratory control processes for use of criteria for establishing appropriate specifications.

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
LaCore Nutraceuticals, Inc.	Food and Cosmetics	03/11/2024	Corrective action plans
LaCore Nutraceuticals, Inc.	Food and Cosmetics	03/11/2024	Batch record - label
LaCore Nutraceuticals, Inc.	Food and Cosmetics	03/11/2024	Criteria for establishing specifications