# FDA 483 - Green Valley Fertility Partners - April 13, 2022

Source: https://www.keypedia.com/records/483/green-valley-fertility-partners/0947b555-cb79-475c-b17a-8a31bf01bd9c

> FDA 483 for Green Valley Fertility Partners on April 13, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Green Valley Fertility Partners
- Inspection Date: 2022-04-13
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Fisch LTD d.b.a Green Valley Fertility Partners received a Form 483 for failing to properly label Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from ineligible donors. Specifically, an oocyte from a donor who tested positive for chlamydia was not labeled with required biohazard and communicable disease risk warnings before being transferred to a recipient. This indicates a serious lapse in donor eligibility and product labeling procedures, posing potential health risks.

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## Related Officers

- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/green-valley-fertility-partners/36bc479f-b769-4cde-a291-a171ae6f69fb

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