National Genetics Institute

Recipient: National Genetics Institute.
Product:HIV-1 and Hepatitis C virus nucleic acid tests
Date: 1/17/2006

FDA District:Los Angeles District Office

Failure to validate computer software used in production; failure to validate the quality system; failure to document validation activities and results; failure to make adequate provisions for monitoring laboratory test procedures and instruments; failure to maintain written standard operating procedures; failure to maintain adequate procedures for testing blood and biologics components; failure to maintain process control procedures; and failure to establish an adequate system for authorizing, granting and rescinding computer access to functions

Issuer:Los Angeles District Office

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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