Over the years, the FDAzilla blog has published over 650 articles. We hope this compilation will serve as a resource for you and your company. It should also help orient you to the scope of the FDAzilla blog as you continue to follow our efforts to provide accessible FDA data and insights.
FDA is expanding its New Inspection Protocol Project (NIPP) inspection methodology, initially piloted exclusively for sterile drug manufacturing facilities, to include other dosage forms, beginning this month.
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.
Lots of reading, including more to OTC manufacturers who continue to fail to understand and implement the fundamentals of GMPs. There is also one warning letter to a cell therapy manufacturer and one to a sponsor-investigator.
JUUL Labs recently received a first-of-its-kind warning letter from CTP. Learn more about the warning letter and what makes it unique.
GMP/GCP compliance failures in the drug product segment are no longer identified as the ‘software not being validated for its intended use’, but rather the deficiencies are now linked to the predicate GMP requirements based on FDA’s stated focus in 2010.
This week, there were two warning letters issued to pharmaceutical firms. But first, we address an EIR associated with AveXis and the second warning letter issued to a firm for failure to comply with the Food Foreign Supplier Verification Program.