# FDA 483 - ClinImmune Labs-Univ Colorado Cord Blood Bank and Stem Cell Lab - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/clinimmune-labs-univ-colorado-cord-blood-bank-and-stem-cell-lab/0697adfd-c18c-4008-a169-a323110b5209

> FDA 483 for ClinImmune Labs-Univ Colorado Cord Blood Bank and Stem Cell Lab on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ClinImmune Labs-Univ Colorado Cord Blood Bank and Stem Cell Lab
- Product Type: biologics
- Office Name: Denver District Office
- Summary: ClinImmune Labs, a cord blood manufacturer in Aurora, CO, was cited for significant deficiencies across its quality control, aseptic processing, and laboratory control systems. Observations included inadequate failure investigations, insufficient personnel training, flawed media fill studies, lack of environmental monitoring data review, and poor access controls for cleanrooms and computer systems. These issues indicate a systemic breakdown in ensuring product quality and safety.

## Related Officers

- [Nicholas M Smith](https://www.globalkeysolutions.net/people/nicholas-m-smith/bacbf9f6-b1a6-41b7-bb31-1d67be012783)
- [Amy A. Johnson](https://www.globalkeysolutions.net/people/amy-a-johnson/9933f793-503f-45c5-8837-d46134c20e09)
- [Cynthia Jim](https://www.globalkeysolutions.net/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

Company: https://www.globalkeysolutions.net/companies/clinimmune-labs-univ-colorado-cord-blood-bank-and-stem-cell-lab/43c022c5-0a4f-45fb-aca4-dc62ae65d841

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face