Business Bites: St Jude resolves warning letter; DePuy Synthes recalls jaw device
This article was originally published in Clinica
The US FDA has told St Jude Medical that violations cited in a 2009 warning letter for the firm’s Plano, Texas neuromodulation device facility have been resolved. The warning letter, based on an inspection of the firm’s Plano plant, highlighted several violations to the quality system regulation. In April, St Jude CEO Daniel Starks said the firm had taken remediation steps at the Texas plant and was awaiting a reinspection of the facility by FDA.