Phrase: "Repeat violation," or worse, "serious and repeat violation"
Subcategory: "Your firm has previously made similar assurances"
From: Apotex warning summary and letter
Like the previous phrase (Despite an incident report from late last year"), repeat-violation phrases carry the message that the time has all but expired for promising or making ops corrections. "Repeat violation" is perhaps the most common term used by the FDA when it describes its need to pursue executive misdemeanor prosecutions for manufacturing issues.
TYA summary and letter