FDA INSPECTION INTELLIGENCE · HUMAN TISSUE FOR TRANSPLANTATION

Most common FDA 483 observations in Human Tissue for Transplantation

The observation types FDA cites most often on Form 483 in Human Tissue for Transplantation 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. #1Risk factors, clinical evidence254 · 197 firms
  2. #2Testing, screening, donor eligibility procedures182 · 154 firms
  3. #3Determination based on screening and testing140 · 120 firms
  4. #4Procedures to meet core CTGP74 · 69 firms
  5. #5Infection with communicable disease agents69 · 56 firms
  6. #6Storage temperatures recorded, maintained65 · 63 firms
  7. #7Eligibility not required--warning labels62 · 54 firms
  8. #8Responsible person to determine, document60 · 52 firms
  9. #9Accurate, indelible, legible54 · 49 firms
  10. #10Specimen collections not timely50 · 48 firms
  11. #11Design of procedures to ensure compliance47 · 44 firms
  12. #12Labeled re: biohazard, risks, test results45 · 44 firms
  13. #13Name and personal info on accompanying records45 · 41 firms
  14. #14Procedures for all other requirements45 · 42 firms
  15. #15Records incomplete37 · 32 firms
  16. #16Donors with risks not determined ineligible36 · 36 firms
  17. #17Listing and interpretation of CD tests performed35 · 33 firms
  18. #18Donor screening standards30 · 28 firms
  19. #19Statement re: certified testing lab29 · 27 firms
  20. #20Procedures and release criteria28 · 27 firms
  21. #21Reasons for ineligibility on summary28 · 26 firms
  22. #22SOP for release; reactive for CMV27 · 26 firms
  23. #23Documentation--determination, by whom, date25 · 23 firms
  24. #24Validation & approval--established procedures24 · 19 firms
  25. #25Records maintained concurrently23 · 23 firms
  26. #26Procedures re complaints22 · 20 firms
  27. #27Return to inventory--procedures22 · 22 firms
  28. #28All core requirements covered in program19 · 18 firms
  29. #29Completion of eligibility determination19 · 18 firms
  30. #30Kits not FDA approved, specifically labeled19 · 17 firms
  31. #31Name and address on summary17 · 17 firms
  32. #32Process validation procedures17 · 17 firms
  33. #33Deviations--evaluation, cause, corrective action15 · 14 firms
  34. #34Cleaned, sanitized per established schedules14 · 13 firms
  35. #35Evaluation--microorganisms, damage14 · 14 firms
  36. #36Summary--records used to make determination14 · 14 firms
  37. #37Abbreviated procedure13 · 12 firms
  38. #38Manufacturer instructions not followed13 · 12 firms
  39. #39Adequate control, proper conditions12 · 12 firms
  40. #40Calibration procedures and schedules (general)12 · 10 firms
  41. #41Deviations--Investigation, documenting, trending12 · 12 firms
  42. #42Periodic review of temperatures12 · 12 firms
  43. #43Retention time (10 year rules)12 · 11 firms
  44. #44Contamination, mix ups, improper release11 · 11 firms
  45. #45Eligibility statement--basis of determination11 · 11 firms
  46. #46Establishing a system11 · 11 firms
  47. #47Monitoring--cross contamination, exposure to CD11 · 11 firms
  48. #48Review and approval of procedures11 · 11 firms
  49. #49Causing contamination, increasing risks10 · 10 firms
  50. #50Documentation of maintenance and cleaning10 · 10 firms