FDA Audit Trends, 2023

Last year FDA inspections were down about 20% compared to years prior to 2019, and food facility inspections accounted for more inspections than all other facilities combined. The most common finding at drug and device manufacturing facilities was SOPs not present or not followed. There are a few other important aspects of FDA audits that … Read more

“Work From Home” No More: FDA Staff Returns to the Office This Month

Starting this month, FDA’s staff will return to their offices in White Oak, outside Washington DC, to a hybrid work-schedule reversing earlier indications from FDA leaders that work from home may become permanent. While it may seem like a big change in the post-pandemic world, it is not. FDA staff have maintained hybrid work schedules … Read more