Portage Times

There were two companies in cities associated with Portage County that received FDA citations as a result of two inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies cited in the previous year.

The citations in the county include:

• Written MDR procedures have not been developed.
• The type and extent of control to be exercised over the product, services and suppliers was not clearly defined.
• Records of acceptable suppliers have not been established.

The companies cited were involved in either Devices or Drugs sectors.

Both 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
Ace Products & Consulting, LLC	Drugs	04/04/2024	Computer control of master formula records
Ace Products & Consulting, LLC	Drugs	04/04/2024	SOPs not followed / documented
Ace Products & Consulting, LLC	Drugs	04/04/2024	No written record of investigation
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