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 (4,780 citations)
DevicesTop 50 observation types
Most cited: Lack of or inadequate procedures (2,368 citations)
DrugsTop 50 observation types
Most cited: Procedures not in writing, fully followed (1,468 citations)
Veterinary MedicineTop 50 observation types
Most cited: Record keeping (795 citations)
Bioresearch MonitoringTop 50 observation types
Most cited: FD-1572, protocol compliance (1,009 citations)
Human Tissue for TransplantationTop 50 observation types
Most cited: Risk factors, clinical evidence (254 citations)
BiologicsTop 50 observation types
Most cited: Establish, maintain and follow manufacturing SOPs (277 citations)
Parts 1240 and 1250Top 35 observation types
Most cited: Prevention of contamination (289 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)