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FDA inspection glossary

Warning letter close-out letter

A close-out letter tells a firm that FDA has evaluated its corrective actions and is satisfied that the violations in a warning letter were addressed. It applies to warning letters issued on or after September 1, 2009.

  • Verified, not promised. It isn't issued on promises. The corrections must be made and verified, usually by a follow-up inspection [1].

Sources

  1. FDA guidance document
  2. FDA guidance document

See the term in real FDA documents. Your first Form 483 or letter is on us.

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