# FDA 483 - CellTrans, Inc. - May 06, 2021

Source: https://www.globalkeysolutions.net/records/483/celltrans-inc/89bad219-38ce-44a8-81d3-1236f579e7a5

> FDA 483 for CellTrans, Inc. on May 06, 2021. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: CellTrans, Inc.
- Inspection Date: 2021-05-06
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: An FDA inspection of CellTrans, Inc. in Chicago, IL, identified one observation related to clinical trial documentation. The firm, acting as a sponsor, failed to include the complete required ClinicalTrials.gov statement in informed consent documents for five subjects. This indicates a deficiency in adhering to regulatory requirements for clinical trial transparency and subject information.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/yuanyuan-li/2043568b-a6ac-4f49-8018-c2c8edda8ac5)
- [investigator](https://www.globalkeysolutions.net/people/jeanne-j-thai/f7b057a4-ab4c-43de-a448-384ff9f8598f)

Company: https://www.globalkeysolutions.net/companies/celltrans-inc/0d24578f-1597-4378-9c9e-f27f4506c3bb

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669