EU investigators found serious deficiencies in aseptic manufacturing during an inspection of the NCPC Hebei Huamin facility in Shijiazhuang, Hebei province.
Inspection officials from Croatia — an EU member state since 2013 — logged 31 deficiencies, including two “critical” and five “major” deficiencies, in the EudraGMDP inspection database.
The two critical deficiencies were in environmental monitoring and the preparation and use of sterile disinfectants for production of antibiotic APIs.
The inspectors found major deficiencies in quality assurance, document control, preparation and handling of sterile packaging material, electronic records and signatures, and manufacturing areas and equipment.
As a result of the violations, the EU barred the drugmaker from supplying cefotaxime sodium, cefuroxime sodium and ceftriaxone sodium pending its compliance with GMP requirements.