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FDA inspection glossary

FDA warning letter

A warning letter is FDA's notice to a company or person that FDA believes it has found significant violations of federal requirements. It asks for a response within a set time.

  • Follow-up. FDA evaluates the response and, if it's inadequate, begins follow-up action; corrections are usually verified by a follow-up inspection [2].

On FDA Intel

Warning letters → /warning-letters. Per-document prices by type are shown on each document page and on the pricing page (/pricing).

Related terms

close-out letterOAIimport alert

Sources

  1. FDA guidance document
  2. FDA guidance document

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