Hitachi In vitro diagnostic (IVD) analyzers

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;

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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