FDA EIR - National Genetics Institute - January 19, 2017

An FDA inspection of National Genetics Institute, a CBER-licensed contract testing laboratory for HIV, HCV, and HBV human plasma, was conducted from January 10-19, 2017. The inspection, performed under CP 7342.008 and applicable CFR parts 600 and 800, revealed significant deficiencies. Key violations centered on data integrity, with electronic records lacking proper audit trails and accountability. Analysts could manipulate raw data, including scanned assay results and exported spreadsheets, without robust controls, independent review, or access to original secured files. Critical computer date and time settings were alterable, and equipment activity logs lacked traceability. Furthermore, the firm implemented substantial changes to its UltraQual® Assay data processing—transitioning from manual to software-driven analysis—without submitting a required supplement or receiving FDA approval. Other issues included inadequate process controls, as testing equipment frequently failed validated specifications without effective root cause analysis. Deficiencies in contamination control documentation were noted following an unexplained increase in HBV contamination, along with failures to adjust equipment preventive maintenance schedules after malfunctions. Finally, a significant percentage of Quality Reportable Events were not initiated within the firm's own procedural deadlines. Management acknowledged the observations and committed to implementing corrective actions.