# FDA 483 - Repro Lab, Inc. - October 16, 2020

Source: https://www.globalkeysolutions.net/records/483/repro-lab-inc/6b339c28-e6fe-47f9-be9d-ad6e831479a1

> FDA 483 for Repro Lab, Inc. on October 16, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Repro Lab, Inc.
- Inspection Date: 2020-10-16
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Repro Lab in New York was cited for significant deficiencies in its HCT/P donor eligibility determination processes during an FDA inspection. The firm failed to adequately screen donors for communicable disease risks like ZIKV, maintain accurate donor records, and establish comprehensive screening procedures. These issues led to the distribution of HCT/Ps from potentially ineligible donors.

## Related Documents

- [483 - 2024-11-19](https://www.globalkeysolutions.net/records/483/repro-lab-inc/b44f205b-cb35-4b0e-a1e0-6f2bf37d5dfd)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/repro-lab-inc/8960714b-ecb8-4b1d-80ad-c0ad8cb96afe

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