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 unchanged from the number of companies cited in the previous month.
The citations in the county include:
- You did not establish and maintain procedures for testing, screening and determining the eligibility of HCT/P donors.
- The summary of records for HCT/Ps did not contain a listing and an interpretation of results of all communicable disease tests performed.
- Donors were not screened by a review of relevant medical records for risk factors 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 |
|---|---|---|---|
| North Hudson IVF Center for Fertility & Gynecology, P.C. | Biologics | 07/02/2024 | Testing, screening, donor eligibility procedures |
| North Hudson IVF Center for Fertility & Gynecology, P.C. | Biologics | 07/02/2024 | Listing and interpretation of CD tests performed |
| North Hudson IVF Center for Fertility & Gynecology, P.C. | Biologics | 07/02/2024 | Risk factors, clinical evidence |
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