Hewlett Packard mgmt. structure must allow independent review of device production records, FDA says.
This article was originally published in The Gray Sheet
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.
You may also be interested in...
Executive appointments at MyoKardia, Scancell Holdings and Sutro Biopharma
The merger between Mylan and Pfizer’s Upjohn unit finally concluded on 16 November 2020, giving Viatris the go ahead for business. The newly-established company has announced receiving tentative approval for its 10mg pediatric dolutegravir tablets from the FDA under the PEPFAR program.
Johnson & Johnson believes personalization via digital holds the key to smoking cessation success as it launches in the UK its app-supported Nicorette QuickMist SmartTrack product.