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 evidence256 · 198 firms
  2. #2Testing, screening, donor eligibility procedures183 · 155 firms
  3. #3Determination based on screening and testing140 · 120 firms
  4. #4Procedures to meet core CTGP75 · 70 firms
  5. #5Infection with communicable disease agents69 · 56 firms
  6. #6Storage temperatures recorded, maintained65 · 63 firms
  7. #7Eligibility not required--warning labels63 · 55 firms
  8. #8Responsible person to determine, document61 · 53 firms
  9. #9Accurate, indelible, legible54 · 49 firms
  10. #10Specimen collections not timely50 · 48 firms
  11. #11Design of procedures to ensure compliance48 · 45 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. #15Donors with risks not determined ineligible37 · 37 firms
  16. #16Records incomplete37 · 32 firms
  17. #17Listing and interpretation of CD tests performed35 · 33 firms
  18. #18Donor screening standards30 · 28 firms
  19. #19Procedures and release criteria29 · 28 firms
  20. #20Statement re: certified testing lab29 · 27 firms
  21. #21Reasons for ineligibility on summary28 · 26 firms
  22. #22SOP for release; reactive for CMV28 · 27 firms
  23. #23Validation & approval--established procedures26 · 20 firms
  24. #24Documentation--determination, by whom, date25 · 23 firms
  25. #25Records maintained concurrently24 · 24 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. #31Process validation procedures18 · 18 firms
  32. #32Name and address on summary17 · 17 firms
  33. #33Cleaned, sanitized per established schedules15 · 14 firms
  34. #34Deviations--evaluation, cause, corrective action15 · 14 firms
  35. #35Summary--records used to make determination15 · 15 firms
  36. #36Evaluation--microorganisms, damage14 · 14 firms
  37. #37Abbreviated procedure13 · 12 firms
  38. #38Calibration procedures and schedules (general)13 · 11 firms
  39. #39Manufacturer instructions not followed13 · 12 firms
  40. #40Adequate control, proper conditions12 · 12 firms
  41. #41Deviations--Investigation, documenting, trending12 · 12 firms
  42. #42Eligibility statement--basis of determination12 · 12 firms
  43. #43Periodic review of temperatures12 · 12 firms
  44. #44Retention time (10 year rules)12 · 11 firms
  45. #45Causing contamination, increasing risks11 · 11 firms
  46. #46Contamination, mix ups, improper release11 · 11 firms
  47. #47Establishing a system11 · 11 firms
  48. #48Monitoring--cross contamination, exposure to CD11 · 11 firms
  49. #49Review and approval of procedures11 · 11 firms
  50. #50Corrective actions10 · 10 firms