Milwaukee City Wire

There was one company in a city associated with Waukesha County that received FDA citations as a result of one inspection conducted in the county in February, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous month.

The citations in the county include:

• An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.
• Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
• Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others.

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 quality.

Company Name	Area of Business	Inspection Date	Issue Cited
Rowena Punzalan, M.D.	Drugs	02/07/2025	FD-1572, protocol compliance
Rowena Punzalan, M.D.	Drugs	02/07/2025	Case history records- inadequate or inadequate
Rowena Punzalan, M.D.	Drugs	02/07/2025	Unanticipated problems