How many companies in cities across Milwaukee County received FDA citations in February?

How many companies in cities across Milwaukee County received FDA citations in February?
Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) — Official Website
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There was one company in a city associated with Milwaukee 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.

Companies located within Milwaukee County Cities and the citations they received in February
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


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