# FDA 483 - US Stem Cell Clinic, LLC - December 07, 2015

Source: https://www.globalkeysolutions.net/records/483/us-stem-cell-clinic-llc/755c1c2e-49b8-4213-9b66-e864e845c397

> FDA 483 for US Stem Cell Clinic, LLC on December 07, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: US Stem Cell Clinic, LLC
- Inspection Date: 2015-12-07
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: This FDA Form 483 details significant deficiencies observed at US Stem Cell Clinic, LLC in Sunrise, FL, during an inspection of its autologous Stromal Vascular Fraction (SVF) manufacturing operations. The firm was cited for numerous failures in aseptic processing, quality control, laboratory controls, record-keeping, and equipment management, indicating a severe lack of adherence to good manufacturing practices. These issues raise concerns about the sterility, identity, strength, quality, and purity of the SVF product administered to patients.

## Related Documents

- [WARNING_LETTER - 2017-05-11](https://www.globalkeysolutions.net/records/warning_letter/us-stem-cell-clinic-llc/22bea09c-22d6-4c25-8706-fe26cd4c4393)
- [483 - 2017-05-11](https://www.globalkeysolutions.net/records/483/us-stem-cell-clinic-llc/cba5e4da-e766-448a-b4c2-3b2b1c44fd86)

## Related Officers

- [Colleen Aspinwall](https://www.globalkeysolutions.net/people/colleen-aspinwall/d3c98644-e796-4a7f-82d0-9c49e93c0940)

Company: https://www.globalkeysolutions.net/companies/us-stem-cell-clinic-llc/936509d3-7a9c-4929-903b-77e37ada1466

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