FDA Took Global View of GMPs, Tweaked Transparency in 2011

As promised, the FDA last year moved to tighten up loose links in the global device supply chain while addressing criticism that agency decisionmaking is too often opaque. GMP spent 2011 keeping you abreast of the latest FDA guidance on manufacturing issues affecting devicemakers, while noting companies that became the subject of significant agency enforcement action. Efforts to secure the global device supply chain were a key FDA concern in 2011, with the agency urging devicemakers to tighten up supplier controls and scrutinize foreign contractors.
The GMP Letter