# FDA 483 - Lucile Salter Packard Children's Hospital Stanford Medicine Fertility and Reproductive Health - April 27, 2023

Source: https://www.keypedia.com/records/483/lucile-salter-packard-childrens-hospital-stanford-medicine-fertility-and-reproductive-health/fa0ef781-44ec-4443-b56f-0faace02af14

> FDA 483 for Lucile Salter Packard Children's Hospital Stanford Medicine Fertility and Reproductive Health on April 27, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lucile Salter Packard Children's Hospital Stanford Medicine Fertility and Reproductive Health
- Inspection Date: 2023-04-27
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Lucile Salter Packard Children's Hospital Stanford Medicine Fertility and Reproductive Health in Sunnyvale, CA, identified a critical issue with communicable disease testing. The firm failed to adhere to manufacturer's instructions for collecting urine specimens from reproductive cell and tissue donors. This non-compliance involved incorrect urine volumes and collection methods, potentially compromising the sensitivity of tests for Chlamydia trachomatis and Neisseria gonorrhea.

## Related Officers

- [Shelley H. Beausoleil](https://www.keypedia.com/people/shelley-h-beausoleil/1212116b-e24d-4bbc-a27a-5c16334d573e)

Company: https://www.keypedia.com/companies/lucile-salter-packard-childrens-hospital-stanford-medicine-fertility-and-reproductive-health/cdffa0c9-0146-4e58-82eb-0b69d70e68f1

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b