FDA INSPECTION INTELLIGENCE
FDA 483 Observations by Program Area
What does FDA cite most often in your industry? Each program area below opens to the observation types FDA writes up most frequently on Form 483 — ranked by real citation counts across every inspection in that area, each linking to a decoded explainer of what it means and how to comply.
Foods
Top 50 observation types
Most cited: Develop FSVP (4,828 citations)
DevicesTop 50 observation types
Most cited: Lack of or inadequate procedures (2,376 citations)
DrugsTop 50 observation types
Most cited: Procedures not in writing, fully followed (1,487 citations)
Veterinary MedicineTop 50 observation types
Most cited: Record keeping (801 citations)
Bioresearch MonitoringTop 50 observation types
Most cited: FD-1572, protocol compliance (1,022 citations)
Human Tissue for TransplantationTop 50 observation types
Most cited: Risk factors, clinical evidence (256 citations)
BiologicsTop 50 observation types
Most cited: Establish, maintain and follow manufacturing SOPs (280 citations)
Parts 1240 and 1250Top 35 observation types
Most cited: Prevention of contamination (291 citations)
Radiologic HealthTop 18 observation types
Most cited: Failure to submit (45 citations)
Part 11 ComplianceTop 2 observation types
Most cited: Procedural requirements (94 citations)