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)
Devices
Top 50 observation types
Most cited: Lack of or inadequate procedures (2,368 citations)
Drugs
Top 50 observation types
Most cited: Procedures not in writing, fully followed (1,468 citations)
Veterinary Medicine
Top 50 observation types
Most cited: Record keeping (795 citations)
Bioresearch Monitoring
Top 50 observation types
Most cited: FD-1572, protocol compliance (1,009 citations)
Human Tissue for Transplantation
Top 50 observation types
Most cited: Risk factors, clinical evidence (254 citations)
Biologics
Top 50 observation types
Most cited: Establish, maintain and follow manufacturing SOPs (277 citations)
Parts 1240 and 1250
Top 35 observation types
Most cited: Prevention of contamination (289 citations)
Radiologic Health
Top 18 observation types
Most cited: Failure to submit (45 citations)
Part 11 Compliance
Top 2 observation types
Most cited: Procedural requirements (94 citations)