FDA 483 Citations

Document control citations appeared more than 40 times on FDA device 483s in fiscal year 2025. This guide explains what investigators found and how to fix approval, distribution and change control.

UDI and GUDID citations appeared more than 110 times on FDA device 483s in fiscal year 2025. This guide explains the label and database requirements and how to answer the citations.

Management responsibility citations appeared more than 100 times on FDA device 483s in fiscal year 2025. Under QMSR, investigators can now read your management review records. Here is how to respond.

Training citations appeared nearly 80 times on FDA device 483s in fiscal year 2025. This guide explains what investigators found, how to respond and what a compliant training system needs under QMSR.

Hazard analysis and preventive control citations appeared more than 500 times on FDA food 483s in fiscal year 2025. This guide explains what investigators found and how to fix the food safety plan.

Sanitary operations under 21 CFR 117.35 drew more than 750 FDA 483 citations at food facilities in fiscal year 2025, led by pest control. This guide explains each citation and how to fix it.

Design control citations appeared nearly 200 times on FDA 483s in fiscal year 2025, led by design change, risk analysis and design validation. This guide covers each one and how to respond.

Internal audit citations appeared more than 80 times on FDA 483s in fiscal year 2025, and QMSR now lets investigators read your audit reports. Here is how to respond and how to fix the audit program.

Medical Device Reporting citations appeared more than 110 times on FDA 483s in fiscal year 2025. This guide explains the MDR procedure and late-report citations and how to answer them.

Process validation drew more than 130 FDA 483 citations for device manufacturers in fiscal year 2025. This guide explains the citations, the requirements and how to respond.

Nonconforming product control drew more than 110 FDA 483 citations for device firms in fiscal year 2025. Here is what the citation means and how to fix both the records and the system.

Purchasing controls drew more than 160 FDA 483 citations for medical device firms in fiscal year 2025. This guide explains the citations, the requirements and the response FDA expects.

Complaint handling was the second most cited medical device observation on FDA 483s in fiscal year 2025. This guide explains the citation, the requirements behind it and how to build a response FDA will accept.

CAPA was the most cited medical device observation on FDA Form 483s in fiscal year 2025. Here is what the citation means, what a credible response contains, and what a compliant CAPA procedure must cover under QMSR.