# FDA 483 - Olgam Life LLC - October 29, 2025

Source: https://www.keypedia.com/records/483/olgam-life-llc/427758c7-db58-4a59-b844-febb3aaace90

> FDA 483 for Olgam Life LLC on October 29, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Olgam Life LLC
- Inspection Date: 2025-10-29
- Product Type: biologics
- Office Name: New York District Office
- Summary: An FDA inspection of Olgam Life LLC, a source plasma establishment in Bronx, NY, revealed three significant observations. The firm failed to consistently follow written standard operating procedures for blood collection, particularly during plasmapheresis. Additionally, the inspection found deficiencies in maintaining quality control and general records, specifically concerning system validation documentation, and noted that equipment used in blood collection was not regularly observed and standardized as required.

## Related Documents

- [483 - 2025-10-29](https://www.keypedia.com/records/483/olgam-life-llc/9161d876-331f-4241-a0f5-d20e5b27635a)

## Related Officers

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

Company: https://www.keypedia.com/companies/olgam-life-llc/bffbcb1a-043f-4651-a867-2ea6a41339cf

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d