FDA issued 2 citations in cities across Orleans County in 2025

Caleb Michaud, Acting Associate Commissioner for External Affairs of FDA
Caleb Michaud, Acting Associate Commissioner for External Affairs of FDA
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There was one company in a city associated with Orleans County that received FDA citations as a result of one inspection conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).

No companies were cited in the previous year.

The citations in the county were ‘Procedures for corrective and preventive action have not been adequately established’ and ‘Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established’.

The company cited should take a voluntary action to correct its 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 and quality.

Companies Located within Orleans County Cities and the Citations They Received in 2025
Company Name Area of Business Inspection Date Issue Cited
Baxter Healthcare Corporation Devices 04/04/2025 Lack of or inadequate procedures
Baxter Healthcare Corporation Devices 04/04/2025 Lack of or inadequate complaint procedures

Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.



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