FDA INSPECTION INTELLIGENCE · FOODS

Most common FDA 483 observations in Foods

The observation types FDA cites most often on Form 483 in Foods 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. #1Develop FSVP4,828 · 3,544 firms
  2. #2Sanitation monitoring1,675 · 1,382 firms
  3. #3Personnel1,609 · 1,407 firms
  4. #4Pest control1,556 · 1,356 firms
  5. #5Sanitary operations - Plant maintenance1,502 · 1,315 firms
  6. #6Manufacturing, processing, packing, holding - Controls1,409 · 1,257 firms
  7. #7HACCP plan implementation1,167 · 927 firms
  8. #8Equipment and utensils - Design and maintenance1,136 · 1,033 firms
  9. #9Plant construction and design951 · 867 firms
  10. #10Food safety hazards885 · 808 firms
  11. #11Sanitary operations - Plant sanitation848 · 798 firms
  12. #12Critical control points826 · 763 firms
  13. #13Sanitary facilities and controls785 · 739 firms
  14. #14Lack of effective pest exclusion780 · 745 firms
  15. #15Evaluation - performance, risk774 · 703 firms
  16. #16Importer verification704 · 526 firms
  17. #17Specifications - identity, purity, strength, composition687 · 563 firms
  18. #18Hazard analysis - Identification of hazard662 · 608 firms
  19. #19Critical limits660 · 579 firms
  20. #20Sanitation of food-contact surfaces - Frequency657 · 600 firms
  21. #21No HACCP plan626 · 577 firms
  22. #22Supplier verification - establish written procedures608 · 552 firms
  23. #23Hazard analysis biological, chemical, physical586 · 518 firms
  24. #24Hazard analysis written584 · 542 firms
  25. #25Approved supplier procedures - importer established574 · 534 firms
  26. #26Process filing562 · 481 firms
  27. #27Monitoring - adequacy539 · 481 firms
  28. #28Screening523 · 508 firms
  29. #29Verification activity before import, periodically522 · 471 firms
  30. #30Hazard Analysis - Identification of Hazard520 · 470 firms
  31. #31Storage and Distribution515 · 481 firms
  32. #32Corrective action plan500 · 440 firms
  33. #33Sanitation Records495 · 454 firms
  34. #34Food safety plan455 · 409 firms
  35. #35Floors, walls and ceilings443 · 425 firms
  36. #36Signed and dated439 · 404 firms
  37. #37Written procedures - quality control operations434 · 371 firms
  38. #38Supplier approval - document426 · 400 firms
  39. #39Component - verify identity, dietary ingredient418 · 349 firms
  40. #40Buildings/sanitary386 · 374 firms
  41. #41Batch record - complete372 · 292 firms
  42. #42Specifications-component purity, strength, composition355 · 296 firms
  43. #43Specifications - finished dietary supplement352 · 346 firms
  44. #44Manufacturing conditions350 · 338 firms
  45. #45Specifications - component identity348 · 291 firms
  46. #46Component - qualify supplier347 · 284 firms
  47. #47Specifications - components345 · 336 firms
  48. #48Verification - record review - frequency344 · 307 firms
  49. #49Sanitation of non-food-contact surfaces - Manner and frequency338 · 311 firms
  50. #50Plant operations - Precautions332 · 316 firms