# FDA 483 - Genecell International, LLC - September 19, 2018

Source: https://www.globalkeysolutions.net/records/483/genecell-international-llc/64a53cb5-7dc6-400b-8bf9-ee7d67794f93

> FDA 483 for Genecell International, LLC on September 19, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genecell International, LLC
- Inspection Date: 2018-09-19
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: This FDA Form 483 was issued to Genecell International, LLC in Doral, FL, a human tissue establishment. The inspection revealed significant deficiencies in process validation, environmental controls, equipment maintenance, corrective actions, and the establishment of critical procedures for donor screening, eligibility determination, and HCT/P receipt and distribution. These issues indicate a lack of adequate controls to prevent contamination and ensure product quality and safety.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/shavon-l-square/6a15df34-1af6-44f7-8874-c8606691f7e0)

Company: https://www.globalkeysolutions.net/companies/genecell-international-llc/166db29c-ee01-4b46-b404-d6c5bca9d386

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6