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

Source: https://www.globalkeysolutions.net/records/483/smart-surgical-inc/5dd4a95a-4c83-46bc-a225-75299c881d2f

> 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: An FDA inspection of Smart Surgical, Inc. in Boise, ID, a biological drug manufacturer and tissue establishment, revealed significant deficiencies across its operations. The firm failed to ensure donor eligibility and proper screening for communicable diseases for its umbilical cord blood and amniotic membrane products. Additionally, critical issues were identified in sterility assurance, process validation, environmental monitoring, component testing, and complaint handling, indicating a systemic lack of control over manufacturing processes.

## Related Documents

- [483 - 2021-03-05](https://www.globalkeysolutions.net/records/483/smart-surgical-inc/9c1bd202-e87a-4ed5-9cc9-d7666b974c91)
- [WARNING_LETTER - 2021-03-05](https://www.globalkeysolutions.net/records/warning_letter/smart-surgical-inc/64b37632-da47-41f2-adc3-8790cf3d6446)

## Related Officers

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

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