FDA Officials Highlight Compliance and Warning Letter Trends

September 18, 2017

CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ.

Data integrity deviations ranked first on a list of recent trends, followed by issues related to the interplay of sponsors and contract manufacturing organizations. Newer trends included suspect supply chain information and weak controls in connection with risky cuts in manufacturing costs.

“If this trend continues, we’ll probably be over 60 warning letters by the end of the year,” Godwin said, in a presentation at the Joint Regulatory Conference of the FDA and the Parenteral Drug Association in Washington, D.C.

The OMQ also issued 25 import alerts, sent four untitled letters and held 21 regulatory meetings with companies this year, he said.

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