Thermo Fisher's Greenville Facility Faces FDA Scrutiny Over Manufacturing Issues
- Thermo Fisher's Greenville facility has been flagged for multiple FDA regulatory violations, particularly concerning contamination prevention and sterilization procedures.
- In a recent FDA inspection, 17 deficiencies were identified in the manufacturing processes for injectable drugs, raising concerns about quality control.
- Despite addressing the issues, experts continue to express concerns about the plant's overall approach to maintaining quality standards.
In the United States, Thermo Fisher Scientific's Greenville facility has faced scrutiny due to repeated FDA regulatory violations over the past decade. Key issues include contamination prevention and inadequate sterilization procedures, which have raised significant concerns regarding the quality control of drug manufacturing. Despite these violations, the FDA has not taken regulatory action, indicating that the issues were resolved satisfactorily and that there was no evidence of patient harm. However, during a May inspection, the FDA identified 17 deficiencies related to the manufacturing of injectable drugs for Sanofi and AstraZeneca, including insufficient visual inspections and improper handling of sterile components. Although Thermo Fisher has addressed these concerns and provided data on drug safety, experts remain wary about the plant's quality control practices. The situation highlights ongoing challenges in ensuring compliance and maintaining high standards in pharmaceutical manufacturing.