Among the areas we cover, FDA posted one warning letter issued to a fertility clinic governed by the HCT/P regulations and one to a compounding pharmacy.
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.
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.