# FDA 483 - Smart Surgical, Inc - March 05, 2021

Source: https://www.globalkeysolutions.net/records/483/smart-surgical-inc/9c1bd202-e87a-4ed5-9cc9-d7666b974c91

> FDA 483 for Smart Surgical, Inc on March 05, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Smart Surgical, Inc
- Inspection Date: 2021-03-05
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Smart Surgical, Inc. in Boise, ID, was inspected and received 11 observations primarily concerning deficiencies in donor eligibility screening for communicable diseases, inadequate aseptic processing controls, and a lack of validated manufacturing and testing processes for their umbilical cord blood and amniotic membrane products. The inspection revealed significant issues with quality control, environmental monitoring, and complaint handling procedures, indicating a systemic failure to ensure product sterility and donor safety.

## Related Documents

- [483 - 2021-03-05](https://www.globalkeysolutions.net/records/483/smart-surgical-inc/5dd4a95a-4c83-46bc-a225-75299c881d2f)
- [WARNING_LETTER - 2021-03-05](https://www.globalkeysolutions.net/records/warning_letter/smart-surgical-inc/64b37632-da47-41f2-adc3-8790cf3d6446)

## Related Officers

- [Richard F Riggle](https://www.globalkeysolutions.net/people/richard-f-riggle/5e0c278a-2e80-47ca-aa1a-80fb88c7f7a1)
- [Travis S. Bradley](https://www.globalkeysolutions.net/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)

Company: https://www.globalkeysolutions.net/companies/smart-surgical-inc/53ae5dab-7611-4083-8598-0ab500c62bbd

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