FDA INSPECTION INTELLIGENCE · PARTS 1240 AND 1250

Most common FDA 483 observations in Parts 1240 and 1250

The observation types FDA cites most often on Form 483 in Parts 1240 and 1250 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 35 observation types

  1. #1Prevention of contamination291 · 233 firms
  2. #2Prevention of the spread of communicable diseases113 · 96 firms
  3. #3Plumbing design, installation, maintenance48 · 45 firms
  4. #4Maintained in good repair46 · 28 firms
  5. #5Sanitary sewers or alternative methods46 · 40 firms
  6. #6Handling to avoid contamination41 · 37 firms
  7. #7Backflow protection40 · 36 firms
  8. #8Contamination32 · 29 firms
  9. #9Adequate and readily accessible28 · 27 firms
  10. #10Identification marks on tanks and piping28 · 22 firms
  11. #11Contamination of passenger stations26 · 23 firms
  12. #12Backflow prevention - general25 · 24 firms
  13. #13Signs for non-potable water25 · 16 firms
  14. #14Equipment for cleaning and flushing23 · 20 firms
  15. #15Adequate facilities for cleaning, bactericidal treatment22 · 18 firms
  16. #16Connections easily cleanable, located and protected20 · 18 firms
  17. #17Clean and sanitary19 · 15 firms
  18. #18Storage and handling after bactericidal treatment17 · 14 firms
  19. #19Soap, sanitary towels, water16 · 14 firms
  20. #20Equipment kept clean15 · 15 firms
  21. #21Thermometers14 · 14 firms
  22. #22Clean and free from flies, rodents, and other vermin13 · 11 firms
  23. #23Storage of perishables11 · 11 firms
  24. #24Cleaning, disinfecting, flushing10 · 9 firms
  25. #25Signs9 · 8 firms
  26. #26Clean hands8 · 8 firms
  27. #27Clean and free of flies and mosquitoes7 · 7 firms
  28. #28Outlets for non-potable water7 · 7 firms
  29. #29Easily cleaned, self-draining6 · 6 firms
  30. #30Cleaning of multiuse eating and drinking utensils5 · 5 firms
  31. #31Container construction5 · 4 firms
  32. #32Designed to permit ready cleaning5 · 5 firms
  33. #33Submittal of construction plans5 · 4 firms
  34. #34Suitable design and construction5 · 3 firms
  35. #35Ventilation and lighting5 · 5 firms