Phrase: "Provide a complete explanation"
From: Warning letter 320-11-003, also to Claris Lifesciences
The key word is "complete." Here's the sentence: "In your response to this letter, address those issues, and also explain why these stereos were being used during the manufacturing process and how the suppliers of these defective stereos were qualified, and provide a complete explanation of how and when Claris became aware of the defect(s)."
The next sentence provides instruction. "In your written response to this letter, provide specific information regarding the requalification of the printing operation, and any formal study conducted to demonstrate the new printing parameters that the response states your firm adopted will prevent recurrence of the problem."
The addition of "specific" and "formal" in the instruction to "complete" in the initial phrase translates to, "the truth, the whole truth, and nothing but the truth."