FDA INSPECTION INTELLIGENCE · DEVICES

Most common FDA 483 observations in Devices

The observation types FDA cites most often on Form 483 in Devices 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. #1Lack of or inadequate procedures2,368 · 1,997 firms
  2. #2Lack of or inadequate complaint procedures1,770 · 1,590 firms
  3. #3Purchasing controls, Lack of or inadequate procedures931 · 816 firms
  4. #4Documentation896 · 792 firms
  5. #5Lack of Written MDR Procedures850 · 798 firms
  6. #6Nonconforming product, Lack of or inadequate procedures836 · 768 firms
  7. #7Lack of or inadequate process validation771 · 672 firms
  8. #8Quality audits - Lack of or inadequate procedures514 · 473 firms
  9. #9Design changes - Lack of or Inadequate Procedures465 · 417 firms
  10. #10Training - Lack of or inadequate procedures383 · 360 firms
  11. #11DMR - not or inadequately maintained371 · 339 firms
  12. #12Calibration, Inspection, etc. Procedures Lack of or Inadequ348 · 315 firms
  13. #13Lack of or inadequate DHR procedures343 · 317 firms
  14. #14Design control - no procedures339 · 316 firms
  15. #15Procedures not adequately established or maintained326 · 307 firms
  16. #16Lack of or inadequate procedures - Acceptance activities322 · 297 firms
  17. #17Design Validation - Risk analysis not performed/inadequate304 · 280 firms
  18. #18Management review - Lack of or inadequate procedures302 · 286 firms
  19. #19Lack of or inadequate final acceptance procedures299 · 284 firms
  20. #20DHR - not or inadequately maintained296 · 281 firms
  21. #21Process control procedures, Lack of or inadequate procedures294 · 276 firms
  22. #22Investigation of device failures289 · 270 firms
  23. #23Complaints283 · 266 firms
  24. #24Environmental control Lack of or inadequate procedures258 · 230 firms
  25. #25DHR content256 · 243 firms
  26. #26Design history file255 · 237 firms
  27. #27Individual Report of Malfunction246 · 222 firms
  28. #28Lack of or inadequate receiving acceptance procedures243 · 230 firms
  29. #29Design validation- Lack of or inadequate procedures230 · 217 firms
  30. #30Quality Audit/Reaudit - conducted193 · 185 firms
  31. #31Investigator non-compliance with agreement/plan/regulations192 · 188 firms
  32. #32Management review - defined interval, sufficient frequency188 · 174 firms
  33. #33Evaluation of suppliers, contractors, etc., requirements179 · 171 firms
  34. #34Training records178 · 170 firms
  35. #35Software validation for automated processes177 · 163 firms
  36. #36Report of Death or Serious Injury164 · 155 firms
  37. #37Lack of procedures, or not maintained157 · 152 firms
  38. #38Lack/Inad procedure-Monitoring/Control of Validated Proces156 · 143 firms
  39. #39Nonconforming product control155 · 150 firms
  40. #40Quality Audits - defined intervals141 · 134 firms
  41. #41Acceptable supplier records, inadequate records137 · 131 firms
  42. #42Product rework procedures, Lack of or inadequate procedures134 · 130 firms
  43. #43Records of complaint investigation132 · 128 firms
  44. #44Maintenance schedule, Lack of or inadequate schedule131 · 124 firms
  45. #45Lack of or inadequate procedures for labeling128 · 122 firms
  46. #46Production processes121 · 116 firms
  47. #47Label to bear a unique device identifier120 · 119 firms
  48. #48Design verification - Lack of or inadequate procedures115 · 110 firms
  49. #49Servicing - Lack of or inadequate procedures114 · 109 firms
  50. #50Documented evaluation113 · 109 firms