Upper Cumberland Times

There was one company in a city associated with Cumberland 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 personnel you identified to perform quality control operations do not have the education, training or experience to perform the assigned functions.
• You did not establish written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement.
• You did not establish an identity specification for each component.

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

The company cited had to take regulatory and/or administrative actions.

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
Warner Herb Company	Food and Cosmetics	02/27/2024	Personnel - quality control personnel - qualified
Warner Herb Company	Food and Cosmetics	02/27/2024	Procedures - calibrating instruments
Warner Herb Company	Food and Cosmetics	02/27/2024	Specifications - component identity
Warner Herb Company	Food and Cosmetics	02/27/2024	Specifications - contamination limits
Warner Herb Company	Food and Cosmetics	02/27/2024	Specifications - contamination limits
Warner Herb Company	Food and Cosmetics	02/27/2024	Specifications - identity, purity, strength, composition
Warner Herb Company	Food and Cosmetics	02/27/2024	Specifications - finished packaging, labeling
Warner Herb Company	Food and Cosmetics	02/27/2024	Written procedures - quality control operations
Warner Herb Company	Food and Cosmetics	02/27/2024	Records - receiving; components, packaging, labels, products
Warner Herb Company	Food and Cosmetics	02/27/2024	Batch record - complete
Warner Herb Company	Food and Cosmetics	02/27/2024	Conditions, controls -protect; microorganisms, contamination
Warner Herb Company	Food and Cosmetics	02/27/2024	Records - manufacturing operations; written procedures
Warner Herb Company	Food and Cosmetics	02/27/2024	Labels - issuance, use
Warner Herb Company	Food and Cosmetics	02/27/2024	Written procedures - holding
Warner Herb Company	Food and Cosmetics	02/27/2024	Records - returned dietary supplement: written procedures
Warner Herb Company	Food and Cosmetics	02/27/2024	Written procedures - product complaint