FDA orders tissue-recovery firm to stop manufacturing
This article was originally published in RAJ Devices
Executive Summary
The US Food and Drug Administration (FDA) has ordered a US human tissue-recovery firm based in Raleigh, North Carolina and its owner, to stop all manufacturing operations after inspections found serious deficiencies in its manufacturing practices. Donor Referral Services and its owner, Philip Guyett, were also ordered to retain the human cells, tissues and cellular and tissue-based products (HCT/Ps) recovered on or after 25 May 2005 and which were still in the company's possession.
You may also be interested in...
Prestige Expands UK Eye Care Range In Response To Consumer Demand
A “great consumer response” to TheraTears in the UK leads Prestige Consumer Healthcare to add TheraTears 5-in-1 Irritation and Redness eye drops to the range.
Who’s Hired? Hikma Recruits New US Generics President
A flurry of top level recruitments made headlines in the past weeks, with the likes of Hikma, Lupin, and Viatris announcing new hires while focusing on their targets for the year.
Organon And Henlius Complete Phase III For Denosumab
Having earlier this year reported positive Phase I data for their partnered denosumab biosimilar candidate, Organon and Shanghai Henlius Biotech have now announced that their HLX14 version has met primary endpoints in a Phase III study.