# FDA 483 - Westlake IVF, LLC - April 01, 2021

Source: https://www.globalkeysolutions.net/records/483/westlake-ivf-llc/f334c2b3-4bbe-4e45-9991-fd2dda0297ce

> FDA 483 for Westlake IVF, LLC on April 01, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Westlake IVF, LLC
- Inspection Date: 2021-04-01
- Product Type: biologics
- Office Name: Division of Southwest Imports
- Summary: Westlake IVF, LLC, a reproductive facility in Austin, TX, was cited for significant deficiencies in donor screening, eligibility determination, and record-keeping practices for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Repeat observations highlight issues with incomplete donor screening questionnaires, inadequate physical examinations, and improper labeling of HCT/Ps from ineligible donors. The firm also failed to maintain complete records of communicable disease testing and lacked adequate procedures for donor eligibility.

## Related Documents

- [483 - 2019-05-31](https://www.globalkeysolutions.net/records/483/westlake-ivf-llc/a748dff7-869a-4b6a-97bc-821f732ba47e)
- [WARNING_LETTER - 2019-05-31](https://www.globalkeysolutions.net/records/warning_letter/westlake-ivf-llc/315f61ba-dbf5-46d0-ae9a-cf5e92af0110)

## 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/division-of-southwest-imports/1a990c0f-8880-49cd-9fdf-e7e450072e5a