Milwaukee City Wire

There were two companies in a city associated with Waukesha County that received FDA citations as a result of two inspections conducted in the county over the fourth quarter of 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 quarter.

The citations in the county include:

• Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
• Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
• You did not conduct and document your hazard analysis.

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
Athea Laboratories, Inc.	Drugs	12/20/2023	Mfg / Processing Operations Area
Athea Laboratories, Inc.	Drugs	12/20/2023	Component identification test
Colectivo Coffee Roasters, Inc.	Food and Cosmetics	11/07/2023	Hazard analysis - Conducted
Colectivo Coffee Roasters, Inc.	Food and Cosmetics	11/07/2023	Supply-chain program - Establish