EC Ohio News

There were two companies in a city associated with Coshocton County that received FDA citations as a result of two inspections conducted in the county throughout 2023, 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 year.

Of the 33 citations issued, the most common citations include:

• You did not establish an identity specification for each component.
• You did not establish component specifications for purity, strength and composition.
• You did not establish product specifications for limits on contamination that may adulterate, or that may lead to adulteration of, the finished dietary supplement.

All of the companies cited were involved in the Food and Cosmetics sector.

Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).

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
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Records - cleaning, pest control
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Procedures - equipment - cleaning, sanitizing
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Documentation - instruments, controls; calibrations
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Specifications - component identity
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Specifications-component purity, strength, composition
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Specifications - contamination limits
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Specifications - contamination limits
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Specifications - identity, purity, strength, composition
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Component - verify identity, dietary ingredient
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Written procedures - quality control operations
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Master manufacturing record - each batch
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Batch record - complete
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Batch record - follow master
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Written procedures - holding
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Records - ret'nd dietary supplement: material review, dispos
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Quality control - processes, specifications, written procedures
Natural Relief, Inc.	Food and Cosmetics	04/14/2023	Quality control operations - master manufacturing record, modifications
Wiley's Finest, LLC	Food and Cosmetics	07/25/2023	Specifications - component identity
Wiley's Finest, LLC	Food and Cosmetics	07/25/2023	Specifications-component purity, strength, composition
Wiley's Finest, LLC	Food and Cosmetics	07/25/2023	Specifications - contamination limits
Wiley's Finest, LLC	Food and Cosmetics	07/25/2023	Specifications - identity, purity, strength, composition
Wiley's Finest, LLC	Food and Cosmetics	07/25/2023	Specifications met - test, examinations; compliance
Wiley's Finest, LLC	Food and Cosmetics	07/25/2023	Quality control operations - tests, examinations; results
Wiley's Finest, LLC	Food and Cosmetics	07/25/2023	Master manufacturing record - each batch
Wiley's Finest, LLC	Food and Cosmetics	07/25/2023	Master manufacturing record - dietary ingredients
Wiley's Finest, LLC	Food and Cosmetics	07/25/2023	Instructions; specifications; packaged, labeled
Wiley's Finest, LLC	Food and Cosmetics	07/25/2023	Master manufacturing record - sampling, tests, examinations
Wiley's Finest, LLC	Food and Cosmetics	07/25/2023	Components; add, verify
Wiley's Finest, LLC	Food and Cosmetics	07/25/2023	Batch record - control number, each lot
Wiley's Finest, LLC	Food and Cosmetics	07/25/2023	Batch record - date, time; maintenance
Wiley's Finest, LLC	Food and Cosmetics	07/25/2023	Batch record - yield
Wiley's Finest, LLC	Food and Cosmetics	07/25/2023	Document; laboratory methodology followed
Wiley's Finest, LLC	Food and Cosmetics	07/25/2023	Tests, examinations - scientifically valid