FDA 483 - Olgam Life LLC - October 29, 2025

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.