Hitachi 3/30/98 In vitro diagnostic analyzers 1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a) (4). This would be a violation of the 1978 Good Manufacturing Practices Regulation, 21 CFR 820.162, inadequate failure investigation. For example, software release versions were not documented as required or...Read More