Tuesday, February 24, 2009

Things to look while writing the response after FDA inspection

-Open with a general statement of intent to comply
-Include a commitment to compliance by top management
-Never admit to guilt or characterize 483 citations as “violations”
-Address each and all individual items on the 483
-Indicate root cause and measures taken to prevent recurrence
-Indicate date corrective action is expected to be completed
-Provide supporting evidence if 483 citation is incorrect (but, don’t be defensive)

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