This report presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.
Among the warning letters we follow, this week FDA posted one to a drug manufacturer, two to device firms, and one to a clinical investigator conducting studies on a device.
The full impact of the pandemic has yet to be felt, and the intricate and proprietary nature of pharma supply chains prevents an overall industry analysis. Considering the current reality, is the JIT model now dead or dying in the pharma industry?
FDA posted three drug GMP warning letters this week to pharmaceutical firms, one to a compounding pharmacy, one to a GLP site, and two to device manufacturers.
In the areas we cover, FDA posted three drug GMP warning letters including one sent to a fertility clinic governed by HCT/P regulations. The other two firms manufacture OTC products. FDA also posted a warning letter to a firm in Ireland, Carahealth, for distributing unapproved and misbranded products related to coronavirus disease.
FDA posted four warning letters in areas we cover: two to pharma firms, including the one to Cipla Limited we’ve been watching for, and two to HTC/P manufacturers. The other pharma warning letter serves as an egregious example of data integrity deficiencies.
A serious concern of many is the security of their supply chain based on its complexity and global nature. We look at the GMP audit program and some options that may be able to help mitigate risk in this area, as well as explain choices made that may be asked during the next health authority inspection.