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 a 33.3% decrease from the number of companies cited in the previous quarter.
Of the 11 citations issued, the most common citations were 'You did not establish and maintain procedures for testing, screening and determining the eligibility of HCT/P donors' and 'HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with the Biohazard legend, a statement warning of communicable disease risks and a statement warning of the reactive test results'.
All of the companies cited were involved in the Biologics sector.
All of the companies cited should take voluntary actions to correct their 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 |
|---|---|---|---|
| American Infertility of New York, P.C. | Biologics | 05/01/2024 | Testing, screening, donor eligibility procedures |
| American Infertility of New York, P.C. | Biologics | 05/01/2024 | Determination based on screening and testing |
| American Infertility of New York, P.C. | Biologics | 05/01/2024 | Responsible person to determine, document |
| American Infertility of New York, P.C. | Biologics | 05/01/2024 | Name and personal info on accompanying records |
| American Infertility of New York, P.C. | Biologics | 05/01/2024 | Accurate, indelible, legible |
| American Infertility of New York, P.C. | Biologics | 05/01/2024 | Labeled re: biohazard, risks, test results |
| California Cryobank, LLC | Biologics | 06/07/2024 | Abbreviated procedure |
| Extend Fertility, LLC | Biologics | 04/19/2024 | Testing, screening, donor eligibility procedures |
| Extend Fertility, LLC | Biologics | 04/19/2024 | Labeled re: biohazard, risks, test results |
| Lenox Hill Hospital | Biologics | 04/01/2024 | Concurrent documentation |
| Lenox Hill Hospital | Biologics | 04/01/2024 | Required records |
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