James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
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.
| 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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