For medical device quality teams
See how FDA writes up quality systems at device makers.
Read real device Form 483s on CAPA, complaint handling and design controls, and test your own quality system against them.
Your quality system, through an investigator's eyes.
Device inspections go deep on the quality system. The 483s FDA wrote at other device makers show exactly which records investigators pulled and what they found missing.
Read real CAPA findings
See how investigators word observations on CAPA, complaints and design controls.
Find your weak systems
See which parts of the quality system FDA cites most, so your internal audit starts there.
Vet your suppliers
Search a component supplier or contract manufacturer by name or FEI number before you qualify it.
Prepare your quality system
Device inspections test the whole quality system. A report from our team shows where FDA is likely to look; the documents show how it writes it up.
Custom report · best fit
A report from our team
Our analysts compare your site's record and your investigator's history with recent device 483s on CAPA, complaints and design controls, and tell you where to focus.
Priced per project
Request a custom reportDocuments
The original documents
Read real device Form 483s and warning letters on CAPA, complaint handling and design controls.
From $99 per document
Browse documentsComplaint files and CAPA records tell the story. Make sure yours is the right one.
How device teams use FDA Intel
Start with the most cited
CAPA, complaints and purchasing controls lead device 483s.
Read similar firms
Recent 483s for devices like yours, in FDA's exact words.
Check the records
Walk your CAPA and complaint files with those findings in hand.
What FDA cites most in device 483s
Share of medical device Form 483s since 2023 that cite each 21 CFR 820 section at least once.
These sections are from the Quality System Regulation that FDA replaced with the QMSR in February 2026. The topics still map across.
See all regulationsQuestions
What do FDA device inspections focus on?
The quality system. Typical areas are corrective and preventive action, complaint handling, design controls, purchasing controls and production and process controls.
Is an FDA Form 483 a violation?
No. A Form 483 lists observations made during an inspection. It is not a final agency decision. Assess each observation and respond with root cause and corrective actions.
Can I search by the wording of an observation?
Yes. Search a phrase such as CAPA or complaint handling and read the matching documents. You can also search by firm, FEI number or investigator.
Do I need a subscription?
No. Documents are bought one by one, with no subscription. Custom reports are priced per project.