When observations are identified during an inspection, it is FDA’s expectation that a firm will remediate the issues. This expectation is even more important if a firm receives a warning letter. Lupin Limited (India) seems to have come up short on both accounts.
In another first-of-a-kind set of warning letters, the FDA and DEA issued joint warning letters to four online networks which are marketing unapproved opioid medicines. Also, we include the warning letter issued to Lupin Limited which seems to show they haven’t corrected their shortcomings since the November 2017 warning letter.
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.
This week, there were a total of five issued warning letters: three were issued to drug manufacturers, one to a compounding pharmacy, and one to a device manufacturer. The first one issued to Deva Holdings addresses severe penicillin cross-contamination.