# FDA 483 - IVF-PGD LAB LLC - February 13, 2019

Source: https://www.globalkeysolutions.net/records/483/ivf-pgd-lab-llc/df4145bd-2216-4af3-9691-6cfb61c75d36

> FDA 483 for IVF-PGD LAB LLC on February 13, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IVF-PGD LAB LLC
- Inspection Date: 2019-02-13
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: An FDA inspection of IVF-PGD LAB LLC in Chicago, IL, identified one observation related to the labeling of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to prominently label cryopreserved semen donor files with appropriate warning statements when donor eligibility determinations had not been performed. This indicates a deficiency in HCT/P labeling practices.

## Related Officers

- [Uruaku A Obasi](https://www.globalkeysolutions.net/people/uruaku-a-obasi/8ff0e6f4-da89-4ec0-86f4-7ebf8cf529b8)

Company: https://www.globalkeysolutions.net/companies/ivf-pgd-lab-llc/8c4107f4-b2e6-4763-81ef-7e9b02b3294c

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669