TAIWAN BIOTECH CO., LTD. – FDA 483, May 21, 2026
Taiwan Biotech Co., Ltd., a drug manufacturer in Taoyuan City, was cited for significant deficiencies in its sterile drug product manufacturing processes. Observations included failures in preventing microbial contamination, inadequate environmental monitoring, unsuitable endotoxin sample containers, and deficient laboratory controls for growth promotion tests. Additionally, employee training for visual inspections was found to be insufficient, indicating a broad range of quality system breakdowns.
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