# FDA 483 - Williams OB/GYN & Associates - May 24, 2021

Source: https://www.keypedia.com/records/483/williams-obgyn-associates/97b29fd9-38ca-4dcc-9f77-e97bb71c9f25

> FDA 483 for Williams OB/GYN & Associates on May 24, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Williams OB/GYN & Associates
- Inspection Date: 2021-05-24
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Williams OB/GYN & Associates, a reproductive establishment in San Dimas, CA, revealed significant deficiencies in their human cells, tissues, and cellular and tissue-based products (HCT/P) program. The firm failed to properly document donor eligibility, adequately screen donors for communicable disease risks like Zika, West Nile Virus, and Syphilis, and perform all required communicable disease testing. Additionally, the firm's standard operating procedures for donor eligibility were found to be inadequate for oocyte donors.

## Related Officers

- [Laurissa S. Flowers](https://www.keypedia.com/people/laurissa-s-flowers/27453525-c2fc-4a05-9cdc-7a1ed884304f)
- [investigator](https://www.keypedia.com/people/ka-l-wong/e624263d-e2c0-4b80-b5d9-ea84e29baa6b)

Company: https://www.keypedia.com/companies/williams-obgyn-associates/25011e70-fa57-4843-bba3-83bdde9c991e

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6