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 FSVP4,780 · 3,512 firms
  2. #2Sanitation monitoring1,648 · 1,360 firms
  3. #3Personnel1,579 · 1,384 firms
  4. #4Pest control1,519 · 1,326 firms
  5. #5Sanitary operations - Plant maintenance1,470 · 1,287 firms
  6. #6Manufacturing, processing, packing, holding - Controls1,385 · 1,237 firms
  7. #7HACCP plan implementation1,148 · 915 firms
  8. #8Equipment and utensils - Design and maintenance1,111 · 1,013 firms
  9. #9Plant construction and design934 · 851 firms
  10. #10Food safety hazards864 · 788 firms
  11. #11Sanitary operations - Plant sanitation826 · 779 firms
  12. #12Critical control points814 · 753 firms
  13. #13Lack of effective pest exclusion779 · 744 firms
  14. #14Sanitary facilities and controls774 · 729 firms
  15. #15Evaluation - performance, risk759 · 689 firms
  16. #16Importer verification693 · 520 firms
  17. #17Specifications - identity, purity, strength, composition686 · 562 firms
  18. #18Sanitation of food-contact surfaces - Frequency650 · 594 firms
  19. #19Critical limits648 · 569 firms
  20. #20Hazard analysis - Identification of hazard616 · 566 firms
  21. #21No HACCP plan616 · 568 firms
  22. #22Supplier verification - establish written procedures591 · 538 firms
  23. #23Hazard analysis written572 · 532 firms
  24. #24Hazard analysis biological, chemical, physical570 · 504 firms
  25. #25Approved supplier procedures - importer established558 · 519 firms
  26. #26Process filing548 · 469 firms
  27. #27Monitoring - adequacy533 · 476 firms
  28. #28Screening523 · 508 firms
  29. #29Hazard Analysis - Identification of Hazard520 · 470 firms
  30. #30Verification activity before import, periodically510 · 459 firms
  31. #31Storage and Distribution509 · 475 firms
  32. #32Corrective action plan494 · 435 firms
  33. #33Sanitation Records486 · 447 firms
  34. #34Floors, walls and ceilings443 · 425 firms
  35. #35Food safety plan438 · 395 firms
  36. #36Written procedures - quality control operations434 · 371 firms
  37. #37Signed and dated430 · 396 firms
  38. #38Supplier approval - document424 · 398 firms
  39. #39Component - verify identity, dietary ingredient397 · 331 firms
  40. #40Buildings/sanitary385 · 373 firms
  41. #41Batch record - complete367 · 288 firms
  42. #42Specifications-component purity, strength, composition355 · 296 firms
  43. #43Manufacturing conditions350 · 338 firms
  44. #44Specifications - component identity348 · 291 firms
  45. #45Verification - record review - frequency339 · 303 firms
  46. #46Component - qualify supplier338 · 278 firms
  47. #47Sanitation of non-food-contact surfaces - Manner and frequency335 · 308 firms
  48. #48Plant operations - Precautions324 · 309 firms
  49. #49Cleaning and sanitizing operations322 · 315 firms
  50. #50Reasonable precautions317 · 304 firms