Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is an increase over the number of companies cited in the previous month.
The citations in the county were 'Donors were not screened by a review of relevant medical records for of communicable disease agents and diseases' and 'Donors were not tested for evidence of infection with relevant communicable disease agents'.
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.
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 |
|---|---|---|---|
| Albrecht Women's Care | Biologics | 05/10/2024 | Risk factors, clinical evidence |
| Albrecht Women's Care | Biologics | 05/10/2024 | Infection with communicable disease agents |
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