FDA INSPECTION INTELLIGENCE · BIOLOGICS

Most common FDA 483 observations in Biologics

The observation types FDA cites most often on Form 483 in Biologics 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. #1Establish, maintain and follow manufacturing SOPs280 · 237 firms
  2. #2Required records100 · 80 firms
  3. #3Concurrent documentation96 · 85 firms
  4. #4Thorough investigations90 · 86 firms
  5. #5Biological product deviation report70 · 67 firms
  6. #6Equipment observed, standardized, calibrated48 · 48 firms
  7. #7Person performing, test results, interpretation42 · 40 firms
  8. #8Following manufacturer's instructions39 · 37 firms
  9. #9Proof Of Identity36 · 34 firms
  10. #10Procedures to maintain records of emergency transfusions35 · 34 firms
  11. #11Maintain and clean equipment34 · 32 firms
  12. #12Provide space for examination29 · 25 firms
  13. #13SOPs for investigations, records26 · 26 firms
  14. #14When to report23 · 22 firms
  15. #15Equipment calibration frequency22 · 22 firms
  16. #16Record review prior to release20 · 20 firms
  17. #17Adverse Reaction- Reports of Investigations18 · 17 firms
  18. #18Arm preparation17 · 16 firms
  19. #19Prevention of contamination15 · 14 firms
  20. #20Schedules and procedures for equipment & calibration15 · 13 firms
  21. #21Provide proper equipment to meet requirements14 · 14 firms
  22. #22Clean & orderly13 · 12 firms
  23. #23Informed consent13 · 13 firms
  24. #24Notification12 · 11 firms
  25. #25Qualifications of responsible personnel12 · 12 firms
  26. #26Additional Medical Assessment Factors11 · 11 firms
  27. #27Adverse Reaction - Investigations11 · 10 firms
  28. #28Maintenance - tracing11 · 10 firms
  29. #29Who must report - manufacturer11 · 11 firms
  30. #30CPR certification9 · 9 firms
  31. #31Blood & Blood Components8 · 7 firms
  32. #32Storage temps./agitation8 · 8 firms
  33. #33Donor's Acknowledgment - Exculpatory language7 · 6 firms
  34. #34Notification w/in 8 weeks7 · 7 firms
  35. #35Safe, sanitary, orderly storage7 · 6 firms
  36. #36Determination of lot numbers and supplies6 · 6 firms
  37. #37Notify Consignees [Collecting Establishment]6 · 3 firms
  38. #38Personnel capabilities6 · 6 firms
  39. #39Physical Assessment Determination - Skin Examination6 · 6 firms
  40. #40Unsuitable donation - release6 · 6 firms
  41. #41Donor medical history5 · 5 firms
  42. #42General requirements - storage5 · 5 firms
  43. #43Ineligible Donor5 · 5 firms
  44. #44Legibility and indelibility5 · 5 firms
  45. #45Maintenance - concurrence5 · 5 firms
  46. #46Medical History Interview5 · 5 firms
  47. #47Provisions to monitor lab test procedures & instruments5 · 4 firms
  48. #48Reporting Requirements - 15-day alert5 · 5 firms
  49. #49Results of testing5 · 5 firms
  50. #50Suitable size, construction, etc.5 · 5 firms