Phrase: "Failure to initiate the complaint investigation promptly"
From: Warning letter 320-11-003, to Claris Lifesciences
The FDA notes that Claris waited nearly two weeks to begin its investigation into the discovery of a swirling mass in an antibiotic by a distributor. The complete sentence is, "In your response to this letter, include your final investigation, assessment, rational[e] and the corrective actions implemented addressing your failure to initiate the complaint investigation promptly."
The FDA is not asking what happened. It's saying, make sure this never happens again.