# FDA 483 - Sound Fertility Care PLLC - February 06, 2020

Source: https://www.globalkeysolutions.net/records/483/sound-fertility-care-pllc/b278adf4-b8c3-4998-b5d2-551b1a832c1a

> FDA 483 for Sound Fertility Care PLLC on February 06, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sound Fertility Care PLLC
- Inspection Date: 2020-02-06
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Sound Fertility Care PLLC in Seattle, WA, was inspected regarding its human reproductive tissue operations, revealing two significant observations. The firm's donor eligibility records for sperm and oocyte donors were found to be inaccurate, with errors in determination dates and missing risk assessments. Additionally, the facility failed to adhere to its standard operating procedure for releasing HCT/Ps from donors reactive for cytomegalovirus.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/peter-s-kessler/f3a9dea7-3a2d-4c86-9ec6-97791f9b6c21)

Company: https://www.globalkeysolutions.net/companies/sound-fertility-care-pllc/9e7d057a-d088-403a-9409-e88fcfa90426

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822