# FDA 483 - Akyut Bayrak, MD. A Professional Corporation - July 21, 2022

Source: https://www.keypedia.com/records/483/akyut-bayrak-md-a-professional-corporation/d561c3a5-7c48-4ac5-aba4-97674f5a3e1f

> FDA 483 for Akyut Bayrak, MD. A Professional Corporation on July 21, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Akyut Bayrak, MD. A Professional Corporation
- Inspection Date: 2022-07-21
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Akyut Bayrak, MD. A Professional Corporation, a human reproductive tissue establishment in Pasadena, CA, was inspected by the FDA. The inspection revealed significant deficiencies in donor screening and testing for communicable disease agents, including a lack of testing for West Nile Virus and inadequate screening for sepsis and high-risk behaviors. Additionally, the firm failed to establish proper procedures for physical examinations and improperly included donor names in HCT/P records.

## Related Officers

- [investigator](https://www.keypedia.com/people/yvonne-c-wilkes/44e7b094-d09a-48f0-a0ee-f1a6506f935a)
- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

Company: https://www.keypedia.com/companies/akyut-bayrak-md-a-professional-corporation/3ef1e6e6-55f8-45a1-876a-fd8a7c3cc93e

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