# FDA 483 - US Stem Cell Clinic, LLC - May 11, 2017

Source: https://www.keypedia.com/records/483/us-stem-cell-clinic-llc/cba5e4da-e766-448a-b4c2-3b2b1c44fd86

> FDA 483 for US Stem Cell Clinic, LLC on May 11, 2017. Product: Biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: US Stem Cell Clinic, LLC
- Inspection Date: 2017-05-11
- Product Type: Biologics
- Office Name: Florida District Office
- Summary: The FDA Form 483 details numerous deficiencies at a facility manufacturing injectable Stromal Vascular Fraction (SVF) from autologous adipose tissue, with at least (b)(4) batches produced between 12/08/2015 and 04/17/2017. The SVF product is administered via various methods including intrathecal, intravenous, intradiscal, intramuscular, or intra-articular.

Key violations include:
- **Lack of Aseptic Process Control:** No established, written, or followed procedures to prevent microbiological contamination, and the aseptic manufacturing process is not validated. This is a repeat deficiency.
- **Inadequate Product Testing:** Failure to perform sterility and endotoxin testing on at least (b)(4) batches of injectable SVF product. This is a repeat deficiency.
- **Environmental Monitoring Deficiencies:** No environmental monitoring in the aseptic processing area.
- **Cleaning and Disinfection Issues:** Use of non-sterile disinfectants and wipes, lack of sporicidal agents, no established cleaning/maintenance procedures for equipment, and observed dust accumulation on air vents. Records of equipment cleaning/sanitizing are lacking. These are repeat deficiencies.
- **Unsuitable Equipment:** Use of a (b)(4) (b)(4) model (b)(4) not certified for sterile compounding applications.
- **Inappropriate Personnel Gowning:** Employees processing injectable SVF use non-sterile masks

## Related Documents

- [483 - 2015-12-07](https://www.keypedia.com/records/483/us-stem-cell-clinic-llc/755c1c2e-49b8-4213-9b66-e864e845c397)
- [WARNING_LETTER - 2017-05-11](https://www.keypedia.com/records/warning_letter/us-stem-cell-clinic-llc/22bea09c-22d6-4c25-8706-fe26cd4c4393)

## Related Officers

- [other](https://www.keypedia.com/people/l-capron/c7a87f86-46cc-4422-a60a-9f566abbffad)
- [Colleen Aspinwall](https://www.keypedia.com/people/colleen-aspinwall/d3c98644-e796-4a7f-82d0-9c49e93c0940)

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9