FDA: 1 company in cities within Washington County received 3 citations in Q1

FDA: 1 company in cities within Washington County received 3 citations in Q1
James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer — Official Website
0Comments

There was one company in a city associated with Washington County that received FDA citations as a result of one inspection conducted in the county over the first quarter of 2025, 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 quarter.

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 Washington County Cities and the citations they received in Q1
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


Related

Milwaukee Panthers Women's Basketball Team

Milwaukee Panthers fall short against Detroit Mercy in Horizon League play-in

The Milwaukee women’s basketball team was eliminated from the 2026 Barbasol Horizon League Basketball Championship after a narrow 69-67 loss to Detroit Mercy in the play-in round.

UW-Milwaukee Panther Arena

Elam and Franklin honored by Horizon League for achievements with Milwaukee Panthers

Stevie Elam and Aaron Franklin of the Milwaukee Panthers men’s basketball team received Horizon League postseason honors, according to an announcement from the conference office.

Klotsche Center indoor track

Milwaukee Panthers secure second place at Horizon League Indoor Championships

The Milwaukee Panthers Men’s Track & Field Team finished second at the Horizon League Indoor Championships, which took place in Youngstown, Ohio.

Trending

The Weekly Newsletter

Sign-up for the Weekly Newsletter from Milwaukee City Wire.