FDA 483 - IBSA PHARMA INC - August 07, 2025

An FDA inspection of IBSA PHARMA INC in Parsippany, NJ, revealed a significant issue regarding their Foreign Supplier Verification Program. The firm failed to establish written procedures for ensuring appropriate verification activities for imported food products, including Thirodium, from IBSA Farmaceutici Italia SRL (Italy). This indicates a lack of control over the safety and compliance of imported goods.