PCI 7 November 2023, 15:44
Temax_Krautz
Owen Mumford 12 January 2022, 17:40

Current Edition

Readying for a US FDA Inspection

The Federal Food, Drug and Cosmetic Act states that domestic drug establishments can be inspected at least once every two years. The inspections can happen more frequently, such as if the drug you are producing is new, or if your facility has a history of cGMP problems. Joseph Pickett at Expert Briefings provides an overview of what you can expect the FDA inspector to do when he or she shows up.

https://international-pharma.com/wp-content/uploads/2013/06/Readying-for-a-US-FDA-Inspection.pdf