# FDA 483 - CellTrans Inc. - June 11, 2021

Source: https://www.keypedia.com/records/483/celltrans-inc/eabc837b-2080-42d9-8ede-acc82db8982e

> FDA 483 for CellTrans Inc. on June 11, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CellTrans Inc.
- Inspection Date: 2021-06-11
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of CellTrans Islet Isolation facility in Chicago, IL, revealed significant deficiencies across its quality unit, aseptic processing, and manufacturing controls. The firm was cited for issues including inadequate sterilization oversight, deficient deviation reporting, release of non-conforming product lots, and poor environmental controls. These observations highlight a systemic lack of adherence to established quality standards and procedures.

## Related Officers

- [Gena Arcy, CSO](https://www.keypedia.com/people/gena-arcy-cso/5e73742f-22df-4750-82a8-430f86192916)
- [Prajakta A. Varadkar](https://www.keypedia.com/people/prajakta-a-varadkar/93c01972-2e91-462e-8c2b-4a6520d3dd3f)
- [Pankaj Amin, CSO](https://www.keypedia.com/people/pankaj-amin-cso/d01a4c72-08cd-409e-99bc-3e54afcbd17a)

Company: https://www.keypedia.com/companies/celltrans-inc/f107fb49-e519-4286-880e-2374e9ffa149

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd