Are you prepared for when the FDA arrives…

by t_king

Are you prepared for when the FDA arrives at your facility?

FDA inspections, 483s and Warning Letters are part of the FDA’s regulatory process to ensure that products created by manufacturers are safe for consumers. FDA inspections involve visiting a manufacturer’s facility to evaluate if they are in compliance with FDA regulations
When the FDA arrives to audit your facility, it’s important to stay calm and be prepared. The best way to do this is by having a plan in place ahead of time that outlines what steps need to be taken when an audit occurs.
First, you should familiarize yourself with current regulations and inspect all areas of your facility for compliance. This includes verifying documentation, checking for any potential contamination sources, testing equipment, and ensuring proper labeling and packaging. You should also ensure that any relevant personnel are available to answer any questions from the auditors.
Once the audit begins, it’s important to remain professional and courteous. Be sure to provide accurate information in response to their questions and cooperate fully with their requests. It’s also important to keep detailed records of all interactions, as the FDA may request this information at a later date.
Finally, if you have any concerns about the audit or the results, be sure to raise these issues with the auditor and document them for future reference. The FDA can provide additional guidance on how to handle any discrepancies that arise during an audit and can help ensure your facility is compliant with all regulations.
By following these steps, you can be better prepared when the FDA arrives to audit your facility and have greater confidence in understanding their expectations. With preparation and knowledge of current regulations, you can rest assured that your facility will pass the inspection with flying colors!
Click here to watch Part 2 of our VP Troy Fugate go into further detail on what to do when the FDA arrives.