FDA INSPECTION INTELLIGENCE · RADIOLOGIC HEALTH

Most common FDA 483 observations in Radiologic Health

The observation types FDA cites most often on Form 483 in Radiologic Health 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 18 observation types

  1. #1Failure to submit45 · 39 firms
  2. #2Certification not based on adequate test/testing program27 · 22 firms
  3. #3Failure to submit, distinct marking26 · 23 firms
  4. #4tests--errors and uncertainties accounted for22 · 13 firms
  5. #5Certification label or tag17 · 17 firms
  6. #6Failure to report13 · 13 firms
  7. #7Class IV "Danger" label12 · 12 firms
  8. #8Quality control procedures11 · 11 firms
  9. #9Aperture label8 · 7 firms
  10. #10Legible reproductions8 · 8 firms
  11. #11Reproduction of affixed information8 · 6 firms
  12. #12Lack of certification of conformance7 · 6 firms
  13. #13Methods, devices, procedures for testing7 · 6 firms
  14. #14Measurements with tap water container6 · 6 firms
  15. #15ID label lacks name and address5 · 5 firms
  16. #16ID label lacks place, month & year of manufacture5 · 5 firms
  17. #17Means to monitor interlocks5 · 5 firms
  18. #18Results of tests5 · 5 firms