Nature Coast Times

There was one company in a city associated with Citrus 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:

• The personnel you identified to perform quality control operations are not qualified to do so and do not have the education, training or experience to perform the assigned functions.
• You did not routinely calibrate, inspect and check the automated, mechanical, or electronic equipment to ensure proper performance.
• You did not establish an identity specification for each component.

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
CT Health Solutions, LLC	Food and Cosmetics	08/23/2023	Personnel - quality control personnel - qualified
CT Health Solutions, LLC	Food and Cosmetics	08/23/2023	Equipment - automated - calibrate, inspect
CT Health Solutions, LLC	Food and Cosmetics	08/23/2023	Specifications - component identity
CT Health Solutions, LLC	Food and Cosmetics	08/23/2023	Specifications-component purity, strength, composition
CT Health Solutions, LLC	Food and Cosmetics	08/23/2023	Specifications met - test, examinations; compliance
CT Health Solutions, LLC	Food and Cosmetics	08/23/2023	Quality control - supplier qualification
CT Health Solutions, LLC	Food and Cosmetics	08/23/2023	Batch record - approved, released, rejected; batch
CT Health Solutions, LLC	Food and Cosmetics	08/23/2023	Metal, foreign material