FDA INSPECTION INTELLIGENCE · VETERINARY MEDICINE

Most common FDA 483 observations in Veterinary Medicine

The observation types FDA cites most often on Form 483 in Veterinary Medicine inspections, ranked by how many times each has been written up. Every line is FDA's own citation text — select one to see what it means, why FDA cites it, and how to comply.

Top 50 observation types

  1. #1Record keeping795 · 747 firms
  2. #2ELDU - producer causes Illegal drug residue566 · 538 firms
  3. #3Preventive Controls185 · 143 firms
  4. #4Drug inventory (control of drugs on premises)177 · 171 firms
  5. #5Hazard Analysis171 · 152 firms
  6. #6Prescribed directions - not followed145 · 134 firms
  7. #7Individual identity of animal(s)139 · 136 firms
  8. #8Introduction/delivery into IS - illegal drug residue127 · 124 firms
  9. #9Drugs prohibited for extralabel use in food-producing animal(s)122 · 118 firms
  10. #10Expired drugs administered112 · 110 firms
  11. #11Records review prior to shipment for slaughter111 · 111 firms
  12. #12Prescribed ELDU - vet causes an illegal drug residue106 · 104 firms
  13. #13Develop FSVP105 · 103 firms
  14. #14Food Safety Plan93 · 86 firms
  15. #15ELDU without veterinary client-patient relationship91 · 89 firms
  16. #16System for administration of drugs57 · 57 firms
  17. #17Pest Control55 · 50 firms
  18. #18Withdrawal period54 · 52 firms
  19. #19Contamination with Mycotoxins/Natural Toxins52 · 44 firms
  20. #20Plant Operations52 · 47 firms
  21. #21Control of treated animals49 · 48 firms
  22. #22Medication status of animal(s)47 · 46 firms
  23. #23Dosage level45 · 45 firms
  24. #24Plant Maintenance43 · 38 firms
  25. #25Adequate procedures for Type A and Type B articles41 · 36 firms
  26. #26Raw Material Controls36 · 32 firms
  27. #27Labeling bagged or bulk deliveries35 · 33 firms
  28. #28Three assays per year32 · 30 firms
  29. #29Species or class29 · 28 firms
  30. #30Sanitation27 · 24 firms
  31. #31Conditions of use26 · 26 firms
  32. #32Route of administration25 · 25 firms
  33. #33Validation of Process or Other Preventive Control25 · 22 firms
  34. #34Vermin and pest infestation25 · 22 firms
  35. #35Cleanout procedures24 · 21 firms
  36. #36Sanitation Controls24 · 20 firms
  37. #37Distribution of feed not in conformance with lawful VFD23 · 21 firms
  38. #38Environmental Monitoring23 · 19 firms
  39. #39Manufacturing, Processing, Packing, Holding - Measures23 · 16 firms
  40. #40Establishment and Implementation of Corrective Action Procedures22 · 20 firms
  41. #41Hazard analysis written21 · 21 firms
  42. #42Prevention of unsafe contamination by equipment21 · 20 firms
  43. #43Record Requirements21 · 18 firms
  44. #44Evaluation - performance, risk20 · 20 firms
  45. #45Supplier verification - establish written procedures20 · 18 firms
  46. #46Approved supplier procedures - importer established19 · 18 firms
  47. #47Grounds19 · 15 firms
  48. #48Establishment and Implementation of Monitoring Preventive Controls18 · 17 firms
  49. #49Holding and Distribution18 · 17 firms
  50. #50Product Testing18 · 17 firms