The Italian Medicines Agency found serious GMP violations during an Oct. 31 inspection of a heparin manufacturing facility in China and recommended that the firm be prohibited from supplying crude heparin sodium to the EU.
The agency’s inspectors found the Yibin Lihao Bio-Technology facility in Sichuan failed to adhere to GMP requirements for active substances in its procedures for drying, primary packaging and secondary packaging. It also found problems with the facility’s testing.
The Italian officials noted 24 GMP deficiencies, including seven categorized as major. The major violations involved contamination risks, issues with buildings and facilities, storage of starting materials, material management, solvent recovery and equipment.