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