While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted. Last year, the FDA made available a description of their new operating model that will ensure integration of review and inspection activities for human drugs. This post dives deep into this model – including new timelines for those of us in the drug industry.
The trick with any FDA inspection preparedness program is to reduce the risk of surprise by understanding FDA history and tendencies. But like most professionals in this industry, you’re probably [...]
How to Prepare for a GMP Inspection for Small and Virtual Companies by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief Preparing for GMP inspections, particularly pre-approval inspections, can be a challenge when [...]
FDA sent 2 warning letters to food companies in November. Violations included adulterated beef and kratom contaminated with salmonella.
Mislabeling, lack of sterility, sub- and superpotent drugs. Here are the latest recalls.
Last week there were a handful of recalls due to the presence of NDEA. Here are the latest.
From lack of sterility to discoloration, here are the latest recalls.
From high concentrations of ibuprofen for infants to a metal shard found in a tablet, here are the latest recalls.
From children’s allergy medicine to antacid tablets containing metal particles, here are the latest recalls.