National Genetics Institute – FDA EIR, Dec 4, 2018

An FDA inspection was conducted at National Genetics Institute (NGI) in Los Angeles, CA, from November 28 to December 4, 2018. NGI operates as a CBER-licensed contract testing laboratory, classified as a medical device manufacturer, specializing in initial screening of human plasma for HIV, HCV, and HBV using PCR methodology. The inspection focused on the company's Corrective and Preventive Action (CAPA) and Production and Process Controls systems, under the Quality System Regulation. Three main deficiencies were noted. Firstly, NGI failed to adequately document corrective and preventive actions for significant Quality Reportable Events (QREs), such as plastic in a specimen tube, a leaking sample, and water damage to equipment. The firm's internal procedures required formal investigations and CAPA initiations for these QREs, but these were not consistently followed. Secondly, the procedures for management review were insufficient; the company's SOP B93 did not specify which critical trend reports, including those for QREs or invalid runs, should be reviewed during management meetings. Lastly, NGI's procedures for accepting incoming materials were inadequate, as key raw material specifications lacked requirements for periodic testing against Certificate of Analysis specifications, an issue noted in a prior inspection that remained uncorrected. A three-item Form FDA-483, Inspectional Observations, was issued. NGI management acknowledged the deficiencies and committed to implementing corrective actions and submitting a written response to the FDA within 15 working days.