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 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.
Lots of warning letters this week issued by the Center for Tobacco Products, including 22 to firms selling flavored, cartridge-based electronic cigarettes. FDA also posted one issued to a drug manufacturer and one to a clinical investigator. We cover the latter two here. And, the Cipla warning letter we referenced last week has not been posted yet.
This week we cover three warning letters: two to pharma firms and one to a clinical investigator.
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Enforcement included only two warning letters this week: we cover one BIMO warning letter and one issued to an OTC drug firm. The OTC firms continue to show that they have a limited grasp of the fundamentals of GMPs required for their product type. Also, Lupin announced that they received a warning letter but FDA has not yet published it.