Lorain Times

There were two companies in cities associated with Lorain 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 a 100% increase over the number of companies cited in the previous year.

The citations in the county include:

• Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards.
• Risk analysis is inadequate and is incomplete.
• Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established.

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.

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
Clovervale Farms, LLC	Food and Cosmetics	03/08/2023	Critical control points
Invacare Corporation	Devices	03/30/2023	Design Validation - Risk analysis not performed/inadequate
Invacare Corporation	Devices	03/30/2023	Purchasing controls, Lack of or inadequate procedures