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FDA inspection glossary

Form FDA 483 (inspectional observations)

A Form FDA 483 is the list of inspectional observations an FDA investigator gives a firm's management at the end of an inspection, when they saw conditions that in their judgment may violate the Food, Drug, and Cosmetic Act.

  • Not a final finding. A 483 is not FDA's final determination of whether a condition is a violation [2].
  • Ordered by significance. Observations are listed in order of risk significance [3].
  • Not a complete list. It isn't meant to be an all-inclusive list of every possible deviation [1].
  • Response window. FDA recommends that firms that respond do so within 15 business days [2].

On FDA Intel

Form 483s →

Related terms

EIR483 responseNAI/VAI/OAIwarning letter

Sources

  1. fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions
  2. FDA guidance document
  3. fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspectional-observations-and-citations

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