Europhartech

The inspection report highlights significant non-conformities and shortcomings at Europhartech's facility in Lempdes. Notified on October 9, 2024, these issues include inadequate risk analysis for cross-contamination in high-activity medicine manufacturing (5.20, 5.21, 1.13 of Good Manufacturing Practices), equipment cleaning validation deficiencies (10.1, 10.6, 10.13 of Annex 15 to GMP), and supplier and subcontractor monitoring shortcomings (BPF points 1.4.vi, 5.27, 5.28, 5.29, 7.4, 7.7, 7.8). The ANSM issues an injunction to Europhartech to update the risk analysis within three months and implement compensatory measures for cleaning methods validation. The company is also required to validate equipment cleaning within 12 months and conduct audits, as well as maintain a CAPA (Corrective Action Preventative Action) process.