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

Source: https://www.keypedia.com/records/483/olgam-life-llc/9161d876-331f-4241-a0f5-d20e5b27635a

> 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: Division of Human and Animal Food Operations - East I
- Summary: Olgam Life LLC, a source plasma establishment in Bronx, NY, was cited for three observations during an FDA inspection. The firm failed to consistently follow written standard operating procedures for blood collection, did not maintain accurate quality control and general records, and lacked regular observation and standardization of equipment used in blood component collection. These issues indicate deficiencies in procedural adherence, record integrity, and equipment management.

## Related Documents

- [483 - 2025-10-29](https://www.keypedia.com/records/483/olgam-life-llc/427758c7-db58-4a59-b844-febb3aaace90)

## 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/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961