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 keeping801 · 751 firms
  2. #2ELDU - producer causes Illegal drug residue569 · 540 firms
  3. #3Preventive Controls186 · 144 firms
  4. #4Drug inventory (control of drugs on premises)178 · 172 firms
  5. #5Hazard Analysis178 · 159 firms
  6. #6Prescribed directions - not followed148 · 137 firms
  7. #7Individual identity of animal(s)141 · 138 firms
  8. #8Introduction/delivery into IS - illegal drug residue129 · 126 firms
  9. #9Drugs prohibited for extralabel use in food-producing animal(s)125 · 121 firms
  10. #10Expired drugs administered112 · 110 firms
  11. #11Records review prior to shipment for slaughter112 · 112 firms
  12. #12Prescribed ELDU - vet causes an illegal drug residue108 · 106 firms
  13. #13Develop FSVP106 · 104 firms
  14. #14Food Safety Plan96 · 89 firms
  15. #15ELDU without veterinary client-patient relationship91 · 89 firms
  16. #16Pest Control58 · 52 firms
  17. #17System for administration of drugs57 · 57 firms
  18. #18Contamination with Mycotoxins/Natural Toxins56 · 47 firms
  19. #19Withdrawal period54 · 52 firms
  20. #20Plant Operations52 · 47 firms
  21. #21Control of treated animals49 · 48 firms
  22. #22Medication status of animal(s)48 · 47 firms
  23. #23Dosage level45 · 45 firms
  24. #24Plant Maintenance44 · 39 firms
  25. #25Adequate procedures for Type A and Type B articles42 · 37 firms
  26. #26Labeling bagged or bulk deliveries36 · 34 firms
  27. #27Raw Material Controls36 · 32 firms
  28. #28Three assays per year32 · 30 firms
  29. #29Species or class30 · 29 firms
  30. #30Sanitation27 · 24 firms
  31. #31Conditions of use26 · 26 firms
  32. #32Sanitation Controls26 · 22 firms
  33. #33Route of administration25 · 25 firms
  34. #34Validation of Process or Other Preventive Control25 · 22 firms
  35. #35Vermin and pest infestation25 · 22 firms
  36. #36Cleanout procedures24 · 21 firms
  37. #37Environmental Monitoring24 · 20 firms
  38. #38Distribution of feed not in conformance with lawful VFD23 · 21 firms
  39. #39Establishment and Implementation of Corrective Action Procedures23 · 21 firms
  40. #40Manufacturing, Processing, Packing, Holding - Measures23 · 16 firms
  41. #41Hazard analysis written21 · 21 firms
  42. #42Prevention of unsafe contamination by equipment21 · 20 firms
  43. #43Record Requirements21 · 18 firms
  44. #44Grounds20 · 16 firms
  45. #45Approved supplier procedures - importer established19 · 18 firms
  46. #46Establishment and Implementation of Monitoring Preventive Controls19 · 18 firms
  47. #47Evaluation - performance, risk19 · 19 firms
  48. #48Supplier verification - establish written procedures19 · 18 firms
  49. #49Holding and Distribution18 · 17 firms
  50. #50Product Testing18 · 17 firms