Phrase: "Because responses were received more than 15 business days after the Form FDA 483 was issued"
From: WL 320-11-002, to CP Pharmaceuticals (Warning letter)
The letter concerns mold in a class 100 production room and holes in a ceiling at a plant in Wrexham, U.K. The phrase is followed by, "...the Form FDA 483 was issued, the responses have not been considered. We plan to evaluate your responses to the Form FDA 483, along with any other written material provided, as a direct response to this Warning Letter."
Expect to see more like this for those whom the regulator may see as viewing the warning as less than a top priority.