# FDA 483 - Life Line Stem Cell, Inc. - January 16, 2026

Source: https://www.keypedia.com/records/483/life-line-stem-cell-inc/53c84117-724a-42d0-b3c9-41e7d66de594

> FDA 483 for Life Line Stem Cell, Inc. on January 16, 2026. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Life Line Stem Cell, Inc.
- Inspection Date: 2026-01-16
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Life Line Stem Cell, Inc. in New Haven, IN, was cited for multiple deficiencies during an FDA inspection of its HCT/P recovery operations. Observations included the failure to clearly identify quarantined HCT/Ps, lack of established temperature limits for HCT/P storage, and inadequate documentation for the verification of supplies and reagents. The firm also failed to follow its own procedures for equipment calibration, specifically for temperature monitoring devices.

## Related Officers

- [Lesley Mae P. Lutao](https://www.keypedia.com/people/lesley-mae-p-lutao/bfdcc755-28e5-4caf-91f9-b9579df4731e)
- [David A. Moore](https://www.keypedia.com/people/david-a-moore/361e4fe8-caf0-4320-963a-3838616850e2)

Company: https://www.keypedia.com/companies/life-line-stem-cell-inc/fcc471ba-2e99-4603-8a69-75c54f78aa14

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0