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

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