# FDA 483 - Westlake IVF, LLC - May 31, 2019

Source: https://www.globalkeysolutions.net/records/483/westlake-ivf-llc/a748dff7-869a-4b6a-97bc-821f732ba47e

> FDA 483 for Westlake IVF, LLC on May 31, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Westlake IVF, LLC
- Inspection Date: 2019-05-31
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: Westlake IVP, LLC, a reproductive facility in Austin, TX, was cited for multiple deficiencies related to donor screening, eligibility determination, and record-keeping for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The inspection revealed failures in screening donors for communicable diseases like ZIKA, improper labeling of HCT/Ps, and inaccurate or illegible donor records. These issues indicate significant non-compliance with HCT/P regulations.

## Related Documents

- [WARNING_LETTER - 2019-05-31](https://www.globalkeysolutions.net/records/warning_letter/westlake-ivf-llc/315f61ba-dbf5-46d0-ae9a-cf5e92af0110)
- [483 - 2021-04-01](https://www.globalkeysolutions.net/records/483/westlake-ivf-llc/f334c2b3-4bbe-4e45-9991-fd2dda0297ce)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/maira-p-brading/892072f4-e584-48d1-890c-e0a47dfbdffa)

Company: https://www.globalkeysolutions.net/companies/westlake-ivf-llc/8bda4bbc-0ea0-47c3-aebc-9452f4202a7c

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9