The FDA has enacted a new policy in which the agency will issue automatic Warning Letters to companies that fail to respond to FDA 483s within 15 days!
This is a significant policy change, and one that is indicative of the increased enforcement posture of the FDA.
Request the 483 Warning Letter Report to read the Seven Strategies.
You can achieve such focus with the following:
Step 1: Create a three-month, strict timeframe for an enforcement risk reduction project. Why three months? Well, for one thing, it’s a manageable timeframe – it is short enough to be real. Also, three months puts pressure and focus (which is what you want) on your team to deliver.
Step 2: Prepare to get things done. If you’ve got a staff of 20 people that are already overworked, you can’t just add more work to their plate. You have to eliminate low-value work items to free staff up for a big project push.