Both medical device companies I have worked at announce all FDA audits in a company-wide email a few days prior and the day of the audit. This is said to give each department time to prepare the required data/documents for presenting to the FDA, but at the same time it also acts as an alert for the staff to be aware of their actions and operations while the FDA auditor is on the premises. All company emails I’ve ever received regarding approaching FDA audits were followed up by notification emails of the auditor concluding the audit and leaving the premises, which seems a bit uncanny.

An online search of FDA audits provides a link as to how the FDA decides to go about their inspections and what medical device manufacturers should expect. For obvious reasons, companies that produce high-risk devices (Class II & III) are subjected to audits at least every other year since high risk devices require more scrutiny, while manufacturers of Class I devices may receive an audit every five years. An FDA inspector will carry out what’s called a Quality System Inspection Technique (QSIT), which is a validated investigation method by an auditor that involves them reviewing procedures, batch records, basic aseptic techniques, GMPs/GDPs, etc. The auditor may provide any recommendations/requirements, such as a protocol being more defined and understandable, ensuring that all testing and facility equipment is calibrated and up-to-date, and that all device/design records and history files are properly stored and organized. The initial audit may also require a follow-up inspection to ensure compliance to FDA standards along with any other post-inspection findings.

Of all the departments in a medical device company, which do you think the FDA comes down on the most (other than quality)? Do departments such as facilities and shipping/packaging expect an as-thorough inspection as quality and manufacturing? Are there any incidents in the history of the FDA where a medical device company was shut down due to its lack of accordance with FDA standards?

https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM466499.pdf