What FDA Sees Before an Inspection: Red Flags in Your Establishment Registration and Device Listings
An FDA inspection does not begin when the investigator badges in at your front desk. It begins weeks earlier, when they pull your data from the FURLS database. What they see determines their "inspection plan"—and whether they arrive with skepticism or confidence.
For small and mid-sized firms, pre-inspection hygiene is critical. If your registration data is messy, it signals to the investigator that your Quality System might also be disorganized. Common "red flags" visible in the public database include inconsistent addresses, products listed that haven't been sold in years, and roles (Manufacturer vs. Contract Manufacturer) that contradict your labeling.
One of the most dangerous signals is a missing or unresponsive U.S. Agent. If an investigator tries to schedule a foreign inspection and your U.S. Agent bounces the email or claims not to know you, you are immediately flagged for closer scrutiny. Similarly, listing a "Contract Manufacturer" role when you are actually the "Specification Developer" creates confusion about who holds the Device Master Record (DMR) and Design History File (DHF).
The "Silent" Audit
Before they arrive, investigators will often compare your device listings against your website. If your website claims "New & Improved!" but your listing shows a 510(k) from 2012, they will likely start the inspection by asking for your Letter to File justifying the changes. This discrepancy can turn a routine surveillance inspection into a "For Cause" investigation focused on misbranding.
How BRS LLC Cleans Your Profile
We ensure your digital footprint tells the same story as your quality manual.
- Pre-Inspection Audit: We review your FURLS profile through the eyes of an investigator, identifying inconsistencies that could trigger deeper questions.
- Role Alignment: We correct your establishment roles to match your actual supply chain contracts, ensuring clear lines of responsibility.
- U.S. Agent Responsiveness: We provide professional U.S. Agent services that guarantee a knowledgeable response to inspection scheduling requests.