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 followed1,468 · 1,238 firms
  2. #2Investigations of discrepancies, failures959 · 805 firms
  3. #3Scientifically sound laboratory controls866 · 743 firms
  4. #4Absence of Written Procedures825 · 704 firms
  5. #5Cleaning / Sanitizing / Maintenance570 · 504 firms
  6. #6Computer control of master formula records487 · 429 firms
  7. #7Equipment Design, Size and Location443 · 395 firms
  8. #8Written procedures not established/followed439 · 394 firms
  9. #9Testing and release for distribution430 · 388 firms
  10. #10Procedures for sterile drug products410 · 327 firms
  11. #11Calibration/Inspection/Checking not done371 · 337 firms
  12. #12Lack of written stability program369 · 336 firms
  13. #13Control procedures to monitor and validate performance357 · 328 firms
  14. #14Environmental Monitoring System309 · 262 firms
  15. #15Training--operations, GMPs, written procedures265 · 243 firms
  16. #16Prepared for each batch, include complete information239 · 222 firms
  17. #17Validation lacking for sterile drug products239 · 207 firms
  18. #18Lack of quality control unit236 · 221 firms
  19. #19Test methods231 · 217 firms
  20. #20SOPs not followed / documented219 · 211 firms
  21. #21Cleaning System213 · 182 firms
  22. #22Written record of investigation incomplete212 · 206 firms
  23. #23Procedures for non-sterile drug products200 · 185 firms
  24. #24Training , Education , Experience overall199 · 188 firms
  25. #25Following/documenting laboratory controls196 · 185 firms
  26. #26Complete test data included in records187 · 173 firms
  27. #27Items to cover on annual reviews187 · 174 firms
  28. #28Complaint Handling Procedure185 · 176 firms
  29. #29Buildings not maintained in good state of repair182 · 170 firms
  30. #30Reports of Analysis (Components)171 · 152 firms
  31. #31Storage under appropriate conditions170 · 158 firms
  32. #32Written program not followed162 · 148 firms
  33. #33Microbiological testing152 · 142 firms
  34. #34GMP Training Frequency151 · 148 firms
  35. #35Expiration date lacking144 · 138 firms
  36. #36No written record of investigation142 · 136 firms
  37. #37Sanitation--buildings not clean, free of infestation141 · 136 firms
  38. #38Establish reliability of supplier's C of A140 · 135 firms
  39. #39Batch production and Batch Control Record Requirements139 · 131 firms
  40. #40Valid stability test methods131 · 124 firms
  41. #41Identity Testing of Each Component127 · 120 firms
  42. #42Records reviewed annually127 · 120 firms
  43. #43Strict control not exercised over labeling issued126 · 120 firms
  44. #44Annual visual exams of drug products124 · 121 firms
  45. #45Procedures to be written and followed123 · 118 firms
  46. #46Procedure Deviations Recorded and Justified111 · 110 firms
  47. #47Lab controls established, including changes110 · 102 firms
  48. #48Authority lacking to review records, investigate errors109 · 103 firms
  49. #49Calibration - at intervals, written program, remedial action109 · 104 firms
  50. #50Quality control unit review of records106 · 100 firms