FDA INSPECTION INTELLIGENCE · DRUGS

Most common FDA 483 observations in Drugs

The observation types FDA cites most often on Form 483 in Drugs 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. #1Procedures not in writing, fully followed1,487 · 1,245 firms
  2. #2Investigations of discrepancies, failures982 · 817 firms
  3. #3Scientifically sound laboratory controls881 · 751 firms
  4. #4Absence of Written Procedures835 · 709 firms
  5. #5Cleaning / Sanitizing / Maintenance581 · 513 firms
  6. #6Computer control of master formula records490 · 431 firms
  7. #7Equipment Design, Size and Location445 · 397 firms
  8. #8Written procedures not established/followed444 · 399 firms
  9. #9Testing and release for distribution431 · 389 firms
  10. #10Procedures for sterile drug products419 · 332 firms
  11. #11Calibration/Inspection/Checking not done374 · 340 firms
  12. #12Lack of written stability program373 · 339 firms
  13. #13Control procedures to monitor and validate performance359 · 329 firms
  14. #14Environmental Monitoring System312 · 265 firms
  15. #15Training--operations, GMPs, written procedures266 · 244 firms
  16. #16Prepared for each batch, include complete information243 · 226 firms
  17. #17Validation lacking for sterile drug products241 · 209 firms
  18. #18Lack of quality control unit239 · 224 firms
  19. #19Test methods232 · 218 firms
  20. #20SOPs not followed / documented220 · 212 firms
  21. #21Cleaning System216 · 184 firms
  22. #22Written record of investigation incomplete215 · 208 firms
  23. #23Procedures for non-sterile drug products202 · 187 firms
  24. #24Training , Education , Experience overall200 · 189 firms
  25. #25Following/documenting laboratory controls197 · 186 firms
  26. #26Items to cover on annual reviews188 · 174 firms
  27. #27Complete test data included in records187 · 173 firms
  28. #28Complaint Handling Procedure185 · 176 firms
  29. #29Buildings not maintained in good state of repair182 · 170 firms
  30. #30Reports of Analysis (Components)172 · 152 firms
  31. #31Storage under appropriate conditions171 · 159 firms
  32. #32Written program not followed164 · 150 firms
  33. #33GMP Training Frequency153 · 149 firms
  34. #34Microbiological testing152 · 142 firms
  35. #35Expiration date lacking144 · 138 firms
  36. #36No written record of investigation143 · 137 firms
  37. #37Establish reliability of supplier's C of A142 · 136 firms
  38. #38Sanitation--buildings not clean, free of infestation142 · 137 firms
  39. #39Batch production and Batch Control Record Requirements140 · 132 firms
  40. #40Valid stability test methods132 · 125 firms
  41. #41Records reviewed annually129 · 122 firms
  42. #42Identity Testing of Each Component128 · 120 firms
  43. #43Strict control not exercised over labeling issued127 · 121 firms
  44. #44Annual visual exams of drug products126 · 122 firms
  45. #45Procedures to be written and followed125 · 120 firms
  46. #46Lab controls established, including changes111 · 103 firms
  47. #47Procedure Deviations Recorded and Justified111 · 110 firms
  48. #48Calibration - at intervals, written program, remedial action110 · 105 firms
  49. #49Authority lacking to review records, investigate errors109 · 103 firms
  50. #50Quality control unit review of records107 · 101 firms