Akron Reporter

There were three companies in cities associated with Summit County that received FDA citations as a result of three inspections conducted in the county throughout 2024, 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:

• You did not have a written food safety plan.
• Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
• There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

All of the companies cited were involved in either Food and Cosmetics, Drugs, or Devices sectors.

All of the companies cited should take voluntary actions to correct their 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.

According to its website, 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.

Company Name	Area of Business	Inspection Date	Issue Cited
A and A Vending, Inc.	Food and Cosmetics	02/22/2024	Food safety plan
GOJO Industries, Inc.	Drugs	04/01/2024	Review of representative number of batches
GOJO Industries, Inc.	Drugs	04/01/2024	Investigations of discrepancies, failures
Omega Laboratories, Inc.	Devices	02/08/2024	Lack of Written MDR Procedures
Omega Laboratories, Inc.	Devices	02/08/2024	Supplier oversight
Omega Laboratories, Inc.	Devices	02/08/2024	Acceptable supplier records, inadequate records
Omega Laboratories, Inc.	Devices	02/08/2024	Lack of or inadequate procedures
Omega Laboratories, Inc.	Devices	02/08/2024	Lack of or inadequate complaint procedures