SE Oakland News

There were two companies in cities associated with Oakland County that received FDA citations as a result of two inspections conducted in the county over the second quarter of 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 quarter.

The citations in the county include:

• You did not implement your sanitation procedures.
• You did not have process control corrective action records.
• Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics 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
Excel Medical Products, Inc.	Devices	04/01/2024	Statistical techniques - Lack of or inadequate procedures
Great Lakes Food Center	Food and Cosmetics	06/05/2024	Sanitation preventive controls - Implement
Great Lakes Food Center	Food and Cosmetics	06/05/2024	Process preventive controls - Implementation records