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 verified to demonstrate that the revisions to the software corrected the problem. Additional deficiencies pertaining to corrective and preventative action include the following:

a. inadequate corrective action to address a recurring software problem with the BM/Hitachi 917 analyzers, resulting in four problem reports to the firm;