FDA warns more contract manufacturers
This article was originally published in The Gold Sheet
Executive Summary
"Here's what we're seeing: A huge growth in warning letters against contract sites," he said. "Our inspection program is not prioritizing contract sites. It's not a risk factor in the model. So I don't think it's a bias of inspection. But sponsor warning letters haven't gone up. All warning letters have gone up, by the way, over that period of time. We're issuing more warning letters. We're issuing way more to contract manufacturers."