Milwaukee City Wire

There were eight companies in cities associated with Waukesha County that received FDA citations as a result of eight inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 38.5% decrease from the number of companies cited in the previous year.

The citations in the county include:

• A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
• Procedures for corrective and preventive action have not been adequately established.
• You did not implement the monitoring and recordkeeping procedures listed in your HACCP plan.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices sector.

All of the 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
Axcesor, Inc.	Devices	06/16/2023	Lack of or inadequate process validation
Axcesor, Inc.	Devices	06/16/2023	Lack of or inadequate procedures
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
Diaspora Tea & Herb Company, LLC	Food and Cosmetics	08/29/2023	Document review entity's hazard analysis
Diaspora Tea & Herb Company, LLC	Food and Cosmetics	08/29/2023	Evaluation - performance, risk
Diaspora Tea & Herb Company, LLC	Food and Cosmetics	08/29/2023	Approved supplier procedures - importer established
Diaspora Tea & Herb Company, LLC	Food and Cosmetics	08/29/2023	Verification activity assurance
Diaspora Tea & Herb Company, LLC	Food and Cosmetics	08/29/2023	Verification activity frequency
Diaspora Tea & Herb Company, LLC	Food and Cosmetics	08/29/2023	Identification - entry
MDS Fulfillment, Inc.	Food and Cosmetics	06/14/2023	Physical plant - repair
MDS Fulfillment, Inc.	Food and Cosmetics	06/14/2023	Written procedures - cleaning
MDS Fulfillment, Inc.	Food and Cosmetics	06/14/2023	Written procedures - pest control
MDS Fulfillment, Inc.	Food and Cosmetics	06/14/2023	Written procedures - holding; distributing
MDS Fulfillment, Inc.	Food and Cosmetics	06/14/2023	Written procedures - returned dietary supplement; salvaged
MDS Fulfillment, Inc.	Food and Cosmetics	06/14/2023	Grounds
Midwest Products and Engineering, Inc.	Devices	04/21/2023	Management ensuring quality policy is understood
Midwest Products and Engineering, Inc.	Devices	04/21/2023	Environmental control Lack of or inadequate procedures
Midwest Products and Engineering, Inc.	Devices	04/21/2023	Product rework documentation, DHR {see also 820.184}
Midwest Products and Engineering, Inc.	Devices	04/21/2023	Documentation
Sasta Bazaar, Inc.	Food and Cosmetics	02/22/2023	Develop FSVP
U. S. Food, Inc.	Food and Cosmetics	01/19/2023	HACCP plan implementation