Hewlett Packard mgmt. structure must allow independent review of device production records, FDA says.
This article was originally published in The Gray Sheet
Executive Summary
HEWLETT PACKARD ORGANIZATIONAL INADEQUACIES FOR GMP COMPLIANCE CITED BY FDA in an Oct. 10 warning letter to Hewlett Packard's Medical Products Group. During a Sept. 17 through Oct. 3 inspection of HP's Andover, Massachusetts facility, the agency noted the firm's "failure to have in place an adequate organizational structure and sufficient personnel to assure that the devices produced by Hewlett Packard are manufactured in accordance with the requirements" of good manufacturing practice regulations, the warning letter states.