# FDA 483 - New Direction Biosciences LLC - June 12, 2015

Source: https://www.globalkeysolutions.net/records/483/new-direction-biosciences-llc/6899db48-6914-4061-8462-b090d0044187

> FDA 483 for New Direction Biosciences LLC on June 12, 2015. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New Direction Biosciences LLC
- Inspection Date: 2015-06-12
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of IntelliCell BioSciences, Inc. in New York, NY, revealed significant deficiencies in the manufacturing of their Stromal Vascular Fraction (SVF) drug products. The firm failed to prevent microbiological contamination, lacked adequate production and process controls, and did not ensure the quality and purity of its products. These issues included unvalidated aseptic processes, equipment, and test methods, as well as the release of drug products without complete testing or proper quality assurance review, impacting patients receiving treatments for various medical conditions.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.globalkeysolutions.net/companies/new-direction-biosciences-llc/5289277b-81d3-46cf-b90f-1046498bebd7

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961