Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
This is an increase over the number of companies cited in the previous year.
The citations in the county include:
- HCT/P donors were not determined to be eligible based on the results of donor screening and testing.
- The summary of records for HCT/Ps did not contain a listing of all communicable disease tests performed.
- Donors were not screened by a review of relevant medical records for risk factors and clinical evidence of communicable disease agents and diseases.
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 |
|---|---|---|---|
| Elite IVF & Fertility Solutions, LLC | Biologics | 07/13/2023 | Determination based on screening and testing |
| Elite IVF & Fertility Solutions, LLC | Biologics | 07/13/2023 | Listing and interpretation of CD tests performed |
| Elite IVF & Fertility Solutions, LLC | Biologics | 07/13/2023 | Risk factors, clinical evidence |
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