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 procedures2,376 · 2,003 firms
  2. #2Lack of or inadequate complaint procedures1,774 · 1,593 firms
  3. #3Purchasing controls, Lack of or inadequate procedures936 · 821 firms
  4. #4Documentation897 · 793 firms
  5. #5Lack of Written MDR Procedures865 · 808 firms
  6. #6Nonconforming product, Lack of or inadequate procedures839 · 770 firms
  7. #7Lack of or inadequate process validation776 · 676 firms
  8. #8Quality audits - Lack of or inadequate procedures515 · 473 firms
  9. #9Design changes - Lack of or Inadequate Procedures466 · 418 firms
  10. #10Training - Lack of or inadequate procedures384 · 361 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 procedures344 · 318 firms
  14. #14Design control - no procedures340 · 317 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/inadequate307 · 283 firms
  18. #18Management review - Lack of or inadequate procedures303 · 286 firms
  19. #19Lack of or inadequate final acceptance procedures301 · 286 firms
  20. #20DHR - not or inadequately maintained297 · 281 firms
  21. #21Process control procedures, Lack of or inadequate procedures294 · 276 firms
  22. #22Investigation of device failures290 · 271 firms
  23. #23Complaints284 · 267 firms
  24. #24Environmental control Lack of or inadequate procedures258 · 230 firms
  25. #25Design history file256 · 238 firms
  26. #26DHR content256 · 243 firms
  27. #27Individual Report of Malfunction249 · 225 firms
  28. #28Lack of or inadequate receiving acceptance procedures245 · 232 firms
  29. #29Design validation- Lack of or inadequate procedures231 · 218 firms
  30. #30Investigator non-compliance with agreement/plan/regulations194 · 190 firms
  31. #31Quality Audit/Reaudit - conducted193 · 185 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 Proces157 · 144 firms
  39. #39Nonconforming product control156 · 151 firms
  40. #40Quality Audits - defined intervals141 · 134 firms
  41. #41Acceptable supplier records, inadequate records138 · 132 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. #46Label to bear a unique device identifier123 · 122 firms
  47. #47Production processes121 · 116 firms
  48. #48Design verification - Lack of or inadequate procedures116 · 111 firms
  49. #49Servicing - Lack of or inadequate procedures114 · 109 firms
  50. #50Documented evaluation113 · 109 firms